search
Back to results

Dexmedetomidine Wound Infiltration in Cesarean Section

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Dexmedetomidine
Ropivacaine
Dexmedetomidine - Ropivacaine
0,9% saline
Sponsored by
Attikon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring dexmedetomidine, ropivacaine, wound infiltration, ceasarean section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pregnancy >37 weeks, ASA I-II, BMI<35

Exclusion Criteria:

  • patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class >2, presence of atrioventricular block, severe systemic disease, multiple gestation, high risk pregnancy, contraindications to epidural technique, a history of severe systemic disease, recreational drug or alcohol use

Sites / Locations

  • Paraskevi K MatsotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine

Ropivacaine

Dexmedetomidine - Ropivacaine

0.9 % saline

Arm Description

Drug: dexmedetomidine (Dexmed) 20 mL solution of dexmedetomidine used for wound infiltration

Drug: ropivacaine 20 mL solution of ropivacaine 0.375% used for wound infiltration

Drug: dexmedetomidine (Dexmed) combined with Drug: ropivacaine 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% used for wound infiltration

Drug:0.9 % saline solution (Normal saline). 20 ml with 0.9 % saline solution used for wound infiltration

Outcomes

Primary Outcome Measures

Pain score
Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10)

Secondary Outcome Measures

morphine consumption
morphine given by PCA (1 mg/ml)(setting: bolus dose 1 ml every 7 min).
overall patient satisfaction
overall patient satisfaction with postoperative analgesia using a 4 point scale

Full Information

First Posted
December 17, 2017
Last Updated
July 19, 2023
Sponsor
Attikon Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03382938
Brief Title
Dexmedetomidine Wound Infiltration in Cesarean Section
Official Title
Wound Infiltration With Dexmedetomidine in Cesarean Section: Effect on Postoperative Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The effects of four different wound infiltration protocols in cesarean section will be investigated on parturient' pain intensity, PCA morphine consumption given, side effects and parturient' overall satisfaction. One group will receive for wound infiltration dexmedetomidine, the second ropivacaine, the third dexmedetomidine combined with ropivacaine, while the last one will receive normal saline (placebo group).
Detailed Description
Parturients undergoing scheduled cesarean section under combined spinal-epidural anesthesia will be included in the study. Women will be randomly allocated according to the type of the solution used for wound infiltration into one of the following four groups using the closed envelop method. Group DEX: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of dexmedetomidine 1γ/kg within Normal Saline will be infiltrated subcutaneously along the skin wound edges. Group ROPI: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of ropivacaine 0.375% will be infiltrated subcutaneously along the skin wound edges. Group DEX-ROPI: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% will be infiltrated subcutaneously along the skin wound edges. Placebo Group: Following the closure of the uterine incision and the rectus fascia, 20 ml with 0.9 % saline solution will be infiltrated subcutaneously along the skin wound edges. In Postanesthesia Care Unit, 2 mg of morphine will be administered bolus epidurally before the removal of the epidural catheter. Postoperative analgesia will be managed with the systematic administration of intravenous paracetamol 1g x 3 /day, oral celecoxib 200mg x 2 /day and PCA morphine (1 mg/ml) (setting: bolus dose 1 ml every 7 min). The total morphine consumption 24 hours after the PCA device initiation will be recorded. Also, ranitidine 50 mg and metoclopramide 10 mg will be given intravenously twice per day, while ondansetron 4 mg will be prescribed to be administered intravenously in case of postoperative nausea or vomiting (max x 3 times/day). Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10) at 1, 3, 6, 12, 18 and 24 hours after the end of surgery from an anesthesiologist who does not know the group assignment. Also, at the same time points, hemodynamic parameters of the parturients, side effects (nausea, vomiting, sedation, pruritus) and complications (fever, infection in the area of the wound infiltration, bleeding) will be recorded, while 24 hours postoperatively the overall patient' satisfaction with her postoperative analgesia management will be assessed using a 4 point scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
dexmedetomidine, ropivacaine, wound infiltration, ceasarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Double (Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Drug: dexmedetomidine (Dexmed) 20 mL solution of dexmedetomidine used for wound infiltration
Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
Drug: ropivacaine 20 mL solution of ropivacaine 0.375% used for wound infiltration
Arm Title
Dexmedetomidine - Ropivacaine
Arm Type
Active Comparator
Arm Description
Drug: dexmedetomidine (Dexmed) combined with Drug: ropivacaine 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% used for wound infiltration
Arm Title
0.9 % saline
Arm Type
Placebo Comparator
Arm Description
Drug:0.9 % saline solution (Normal saline). 20 ml with 0.9 % saline solution used for wound infiltration
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmed
Intervention Description
WOUND INFILTRATION IN CESAREAN SECTION
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Ropi
Intervention Description
WOUND INFILTRATION IN CESAREAN SECTION
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine - Ropivacaine
Other Intervention Name(s)
Dexmed Ropi
Intervention Description
WOUND INFILTRATION IN CESAREAN SECTION
Intervention Type
Other
Intervention Name(s)
0,9% saline
Other Intervention Name(s)
normal saline
Intervention Description
placebo WOUND INFILTRATION IN CESAREAN SECTION
Primary Outcome Measure Information:
Title
Pain score
Description
Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10)
Time Frame
up to 24 hours after the end of surgery
Secondary Outcome Measure Information:
Title
morphine consumption
Description
morphine given by PCA (1 mg/ml)(setting: bolus dose 1 ml every 7 min).
Time Frame
24 hours after the PCA device initiation will be recorded
Title
overall patient satisfaction
Description
overall patient satisfaction with postoperative analgesia using a 4 point scale
Time Frame
24 hours after the end of surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pregnancy >37 weeks, ASA I-II, BMI<35 Exclusion Criteria: patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class >2, presence of atrioventricular block, severe systemic disease, multiple gestation, high risk pregnancy, contraindications to epidural technique, a history of severe systemic disease, recreational drug or alcohol use
Facility Information:
Facility Name
Paraskevi K Matsota
City
Athens
State/Province
Other
ZIP/Postal Code
13231
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paraskevi K Matsota, Assoc Prof
Phone
00306945544563
Email
matsota@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Paraskevi Mastota, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Dexmedetomidine Wound Infiltration in Cesarean Section

We'll reach out to this number within 24 hrs