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NCT Number: NCT03382938

Dexmedetomidine Wound Infiltration in Cesarean Section

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).

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Paraskevi K Matsota

Athens, Other, 13231, Greece

Location status: Recruiting

Location contact

Paraskevi K Matsota, Assoc Prof

CONTACT

[email protected]

00306945544563

Paraskevi Mastota, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

WOUND INFILTRATION IN CESAREAN SECTION

Other names: Dexmed

Ropivacaine

Drug

WOUND INFILTRATION IN CESAREAN SECTION

Other names: Ropi

Dexmedetomidine - Ropivacaine

Drug

WOUND INFILTRATION IN CESAREAN SECTION

Other names: Dexmed Ropi

0,9% saline

Other

placebo WOUND INFILTRATION IN CESAREAN SECTION

Other names: normal saline

Primary outcomes

  1. Pain score

    Time frame: up to 24 hours after the end of surgery

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

Secondary outcomes

  1. morphine consumption

    Time frame: 24 hours after the PCA device initiation will be recorded

    morphine given by PCA (1 mg/ml)(setting: bolus dose 1 ml every 7 min).

  2. overall patient satisfaction

    Time frame: 24 hours after the end of surgery

    overall patient satisfaction with postoperative analgesia using a 4 point scale

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Dec 26, 2017
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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