Dexmedetomidine Wound Infiltration in Cesarean Section

NCT ID: NCT03382938

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2026-11-20

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Ropivacaine

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

WOUND INFILTRATION IN CESAREAN SECTION

Dexmedetomidine

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

WOUND INFILTRATION IN CESAREAN SECTION

Dexmedetomidine - Ropivacaine

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine - Ropivacaine

Intervention Type: DRUG

WOUND INFILTRATION IN CESAREAN SECTION

0.9 % saline

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

Group Type: PLACEBO_COMPARATOR

0,9% saline

Intervention Type: OTHER

placebo WOUND INFILTRATION IN CESAREAN SECTION

Interventions

Dexmedetomidine

WOUND INFILTRATION IN CESAREAN SECTION

Intervention Type: DRUG

Ropivacaine

WOUND INFILTRATION IN CESAREAN SECTION

Intervention Type: DRUG

Dexmedetomidine - Ropivacaine

WOUND INFILTRATION IN CESAREAN SECTION

Intervention Type: DRUG

0,9% saline

placebo WOUND INFILTRATION IN CESAREAN SECTION

Intervention Type: OTHER

Other Intervention Names

Dexmed; Ropi; Dexmed Ropi; normal saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Attikon Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paraskevi Matsota

Assoc Prof of Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Paraskevi K Matsota

Athens, Other, Greece

Site Status: RECRUITING

Countries

Greece

Facility Contacts

Paraskevi K Matsota, Assoc Prof

Role: primary

matsota@yahoo.gr

00306945544563

Other Identifiers

WIWDICS

Identifier Type: -

Identifier Source: org_study_id