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Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

Primary Purpose

Obstetric Pain

Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)
Spinal Anesthesia
intrathecal morphine
Ropivacaine (Ropivacaina Molteni®)
Normal saline
Sponsored by
Saint-Joseph University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Pain focused on measuring Ropivacaine, wound infusion, analgesia, cesarean, intrathecal morphine, randomized controlled trial

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • women.
  • age between 18 and 50 years.
  • gestational age 37 to 42 weeks.
  • body mass index ranging from 18.0 to 30.0 kg/m2
  • American Society of Anesthesiology (ASA) physical status I or II
  • elective cesarean delivery with a Pfannenstiel incision
  • spinal anesthesia.

Exclusion Criteria:

  • history of chronic opioid use.
  • Allergy to opioids and or local anesthetics.
  • absolute or relative contraindication to neuraxial anesthesia.
  • fever or any other sign of infection.
  • Diabetes Mellitus under insulin therapy
  • physical separation of patients from the neonate during the postoperative period.

Sites / Locations

  • Hotel Dieu de France Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo (P)

Ropivacaine (R)

Arm Description

Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).

Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).

Outcomes

Primary Outcome Measures

pain at rest
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at rest
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at rest
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at rest
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at rest
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at rest
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at rest
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.

Secondary Outcome Measures

pain at mobilization
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at mobilization
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at mobilization
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at mobilization
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at mobilization
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at mobilization
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
pain at mobilization
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of urinary retention
defined as the requirement of bladder recatheterization postoperatively.
return of gastrointestinal function
interval from the end of surgery until first gas elimination postoperatively. interval from the end of surgery until first feces elimination postoperatively.
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.

Full Information

First Posted
March 23, 2018
Last Updated
October 8, 2018
Sponsor
Saint-Joseph University
Collaborators
LEVENTON
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1. Study Identification

Unique Protocol Identification Number
NCT03502642
Brief Title
Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Official Title
Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
June 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint-Joseph University
Collaborators
LEVENTON

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cesarean delivery is one of the most common surgical procedures, performed at an increasingly high rate. It is associated with intense postoperative pain that may hamper the rehabilitation process and interfere with patient satisfaction and care provided to the newborn. Therefore, control of perioperative pain with multimodal regimens using local anesthetic may be important in short- and long-term convalescence after surgery. Opioid-based regimens are the "gold standard" of cesarean delivery analgesia. However, spinal and epidural opioids have a ceiling effect. Wound infiltration with local anesthetics has been used widely in the multimodal approach of pain relief. Continuous wound infusion with local anesthetic through a multiorifice catheter increases the duration of action and efficacy of local surgical wound infiltration compared with a one-time wound injection of local anesthetic. After cesarean delivery, Local anesthetic continuous wound infusion would be associated with better reduction in pain scores when compared to intrathecal morphine . Therefore, an assessor and patient blinded, randomized study that aimed to compare the efficacy and side effects of these analgesia techniques was conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Pain
Keywords
Ropivacaine, wound infusion, analgesia, cesarean, intrathecal morphine, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
healthy, term women scheduled for cesarean delievry
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (P)
Arm Type
Placebo Comparator
Arm Description
Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
Arm Title
Ropivacaine (R)
Arm Type
Active Comparator
Arm Description
Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
Intervention Type
Device
Intervention Name(s)
wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)
Other Intervention Name(s)
wound catheter
Intervention Description
After peritoneum closure a 16cm multiorifice perforated catheter (Dosi-Pain® Kit, LEVENTON SAU, Spain) was inserted by the surgeon below the fascia used for normal saline continuous infusion in the Placebo group and for continuous ropivacaine infusion (Ropivacaina Molteni®, MOLTENI FARMACEUTICI, Italy) in the ropivacaine group.
Intervention Type
Procedure
Intervention Name(s)
Spinal Anesthesia
Intervention Description
Cesarean section was conducted under spinal anesthesia in both groups
Intervention Type
Drug
Intervention Name(s)
intrathecal morphine
Intervention Description
Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group
Intervention Type
Drug
Intervention Name(s)
Ropivacaine (Ropivacaina Molteni®)
Intervention Description
A10ml bolus of ropivacaine 7.5mg/ml were administered in the wound catheter after skin closure then an infusion of ropivacaine 2mg/ml at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Placebo
Intervention Description
A10ml bolus of normal saline were administered in the wound catheter after skin closure then an infusion of normal saline at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.
Primary Outcome Measure Information:
Title
pain at rest
Description
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 0, Hour 2, Hour 6, Hour 12, Hour 24, Hour 36 and Hour 48
Title
pain at rest
Description
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 2
Title
pain at rest
Description
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 6
Title
pain at rest
Description
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 12
Title
pain at rest
Description
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 24
Title
pain at rest
Description
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 36
Title
pain at rest
Description
Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 48
Secondary Outcome Measure Information:
Title
pain at mobilization
Description
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 0
Title
pain at mobilization
Description
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 2
Title
pain at mobilization
Description
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 6
Title
pain at mobilization
Description
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 12
Title
pain at mobilization
Description
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 24
Title
pain at mobilization
Description
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 36
Title
pain at mobilization
Description
Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 48
Title
incidence of postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 0
Title
incidence of postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 2
Title
incidence of postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 6
Title
incidence of postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 12
Title
incidence of postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 24
Title
incidence of postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 36
Title
incidence of postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 48
Title
incidence of pruritus
Description
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 0
Title
incidence of pruritus
Description
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 2
Title
incidence of pruritus
Description
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 6
Title
incidence of pruritus
Description
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 12
Title
incidence of pruritus
Description
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 24
Title
incidence of pruritus
Description
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 36
Title
incidence of pruritus
Description
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 48
Title
incidence of urinary retention
Description
defined as the requirement of bladder recatheterization postoperatively.
Time Frame
during the 48 hours postoperatively
Title
return of gastrointestinal function
Description
interval from the end of surgery until first gas elimination postoperatively. interval from the end of surgery until first feces elimination postoperatively.
Time Frame
during the 48 hours postoperatively
Title
sedation
Description
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 0
Title
sedation
Description
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 2
Title
sedation
Description
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 6
Title
sedation
Description
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 12
Title
sedation
Description
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 24
Title
sedation
Description
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 36
Title
sedation
Description
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 48
Title
incidence of neurological alterations
Description
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 0
Title
incidence of neurological alterations
Description
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 2
Title
incidence of neurological alterations
Description
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 6
Title
incidence of neurological alterations
Description
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 12
Title
incidence of neurological alterations
Description
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 24
Title
incidence of neurological alterations
Description
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 36
Title
incidence of neurological alterations
Description
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time Frame
Hour 48

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women. age between 18 and 50 years. gestational age 37 to 42 weeks. body mass index ranging from 18.0 to 30.0 kg/m2 American Society of Anesthesiology (ASA) physical status I or II elective cesarean delivery with a Pfannenstiel incision spinal anesthesia. Exclusion Criteria: history of chronic opioid use. Allergy to opioids and or local anesthetics. absolute or relative contraindication to neuraxial anesthesia. fever or any other sign of infection. Diabetes Mellitus under insulin therapy physical separation of patients from the neonate during the postoperative period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hicham A Abou Zeid, M.D.
Organizational Affiliation
Saint Joseph University- Lebanon
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nicole M Naccahe, M.D.
Organizational Affiliation
Saint Joseph University- Lebanon
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samer H Hotayt, M.D.
Organizational Affiliation
Saint Joseph University- Lebanon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu de France Hospital
City
Beirut
ZIP/Postal Code
166830
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No

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Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

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