Dexmedetomidine Wound Infiltration in Cesarean Section

Wound Infiltration with Dexmedetomidine in Cesarean Section: Effect on Postoperative Analgesia

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).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Dexmedetomidine - Ropivacaine; Other: 0,9% saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Other
    • Athens, Other, Greece, 13231
      • Recruiting
      • Paraskevi K Matsota
      • Contact: Paraskevi K Matsota, Assoc Prof; Phone Number: 00306945544563; Email: matsota@yahoo.gr
      • Contact: Paraskevi Mastota, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine; Drug: dexmedetomidine (Dexmed) 20 mL solution of dexmedetomidine used for wound infiltration	Drug: Dexmedetomidine; WOUND INFILTRATION IN CESAREAN SECTION; Other Names: Dexmed
Active Comparator: Ropivacaine; Drug: ropivacaine 20 mL solution of ropivacaine 0.375% used for wound infiltration	Drug: Ropivacaine; WOUND INFILTRATION IN CESAREAN SECTION; Other Names: Ropi
Active Comparator: Dexmedetomidine - Ropivacaine; Drug: dexmedetomidine (Dexmed) combined with Drug: ropivacaine 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% used for wound infiltration	Drug: Dexmedetomidine - Ropivacaine; WOUND INFILTRATION IN CESAREAN SECTION; Other Names: Dexmed Ropi
Placebo Comparator: 0.9 % saline; Drug:0.9 % saline solution (Normal saline). 20 ml with 0.9 % saline solution used for wound infiltration	Other: 0,9% saline; placebo WOUND INFILTRATION IN CESAREAN SECTION; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10)	up to 24 hours after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	morphine given by PCA (1 mg/ml)(setting: bolus dose 1 ml every 7 min).	24 hours after the PCA device initiation will be recorded
overall patient satisfaction	overall patient satisfaction with postoperative analgesia using a 4 point scale	24 hours after the end of surgery

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: December 17, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: dexmedetomidine; ropivacaine; wound infiltration; ceasarean section
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Ropivacaine; Dexmedetomidine
• Other Study ID Numbers: WIWDICS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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