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Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ropivacaine
Morphine
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring cesarean section, spinal anesthesia, continuous wound infiltration, intrathecal morphine, oral morphine

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective Cesarean section
  • Spinal anesthesia
  • Singleton
  • ASA ( Physical status score) 1 to 3

Exclusion Criteria:

  • Age <18yrs
  • BMI ≥ 45 kg/m2 or weight < 45 kg
  • Refusal to consent
  • Urgent cesarean section
  • Allergy to a medication used in the protocol
  • Impaired hemostasis ou current infection
  • Contra indication or failure of spinal anesthesia

Sites / Locations

  • Maternité Régionale Universitaire (MRU)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Continuous wound infiltration alone

Intrathecal moprhine alone

Intrathecal morphine&wound infiltration

Arm Description

Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 1 ml sodium chloride 0.9% (without morphine). Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter.

Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of sodium chloride 0.9% 8 ml/H via a preperitoneal catheter.

Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter.

Outcomes

Primary Outcome Measures

Morphine consumption during the first 48 postoperative hours

Secondary Outcome Measures

Pain at rest and at mobilization
The pain at rest and at mobilization will be evaluated with both Visual Analog scale and Verbal pain scale. The patient should describe the worst pain felt during the previous 4 hours in a lying position and at mobilization
Time to restoration of bowel function
Verbal and Visual analog pain scores in the first standing position
Number of patients that required oral morphine
Number of patients that required local anesthetic rescue dose through the catheter
Postoperative rehabilitation survey
Occurrence of side effect
Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire
Postoperative residual pain (DN4 survey)

Full Information

First Posted
October 16, 2014
Last Updated
October 28, 2014
Sponsor
Central Hospital, Nancy, France
Collaborators
Maternite Regionale Universitaire
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1. Study Identification

Unique Protocol Identification Number
NCT02279628
Brief Title
Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section
Official Title
Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
Maternite Regionale Universitaire

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.
Detailed Description
The aim of this study is to compare the efficacy of continuous wound infiltration versus intrathecal morphine for postoperative analgesia after scheduled cesarean section. The primary endpoint is morphine consumption during the first 48 postoperative hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
cesarean section, spinal anesthesia, continuous wound infiltration, intrathecal morphine, oral morphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous wound infiltration alone
Arm Type
Experimental
Arm Description
Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 1 ml sodium chloride 0.9% (without morphine). Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter.
Arm Title
Intrathecal moprhine alone
Arm Type
Active Comparator
Arm Description
Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of sodium chloride 0.9% 8 ml/H via a preperitoneal catheter.
Arm Title
Intrathecal morphine&wound infiltration
Arm Type
Experimental
Arm Description
Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period
Primary Outcome Measure Information:
Title
Morphine consumption during the first 48 postoperative hours
Time Frame
at the 48th hour
Secondary Outcome Measure Information:
Title
Pain at rest and at mobilization
Description
The pain at rest and at mobilization will be evaluated with both Visual Analog scale and Verbal pain scale. The patient should describe the worst pain felt during the previous 4 hours in a lying position and at mobilization
Time Frame
Every 4 hours during the first 48 postoperative hours
Title
Time to restoration of bowel function
Time Frame
within the first 48 postoperative hours
Title
Verbal and Visual analog pain scores in the first standing position
Time Frame
at day 1
Title
Number of patients that required oral morphine
Time Frame
At the 24th and 48th hour
Title
Number of patients that required local anesthetic rescue dose through the catheter
Time Frame
At the 24th and 48th hour
Title
Postoperative rehabilitation survey
Time Frame
At the 48th hour
Title
Occurrence of side effect
Description
Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire
Time Frame
During the first 48 hours
Title
Postoperative residual pain (DN4 survey)
Time Frame
At 3 months postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective Cesarean section Spinal anesthesia Singleton ASA ( Physical status score) 1 to 3 Exclusion Criteria: Age <18yrs BMI ≥ 45 kg/m2 or weight < 45 kg Refusal to consent Urgent cesarean section Allergy to a medication used in the protocol Impaired hemostasis ou current infection Contra indication or failure of spinal anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence VIAL, MD
Phone
+ 33 3 83 34 43 67
Email
f.vial@maternite.chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe GUERCI, MD
Phone
+33 3 83 15 73 99
Email
p.guerci@chu-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé BOUAZIZ, MD., PhD.
Organizational Affiliation
Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Florence VIAL, MD.
Organizational Affiliation
Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe GUERCI, MD
Organizational Affiliation
Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternité Régionale Universitaire (MRU)
City
Nancy
State/Province
Lorraine
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence VIAL, MD
Phone
+33 3 83 34 44 67
Email
f.vial@maternite.chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Hervé BOUAZIZ, MD., PhD.
Phone
+33 3 83 34 44 67
Email
h.bouaziz@chu-nancy.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
35274209
Citation
Viviand C, Pietretti E, Luc A, Herbain D, Baka N, Morel O, Feugeas J, Aron C, Bouaziz H, Guerci P, Vial F. Continuous wound infusion combined with intrathecal morphine for analgesia after Cesarean delivery compared with intrathecal morphine or continuous wound infusion alone. Can J Anaesth. 2022 Jun;69(6):788-789. doi: 10.1007/s12630-022-02223-2. Epub 2022 Mar 10.
Results Reference
derived

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Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section

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