Dexmedetomidine Wound Infiltration in Cesarean Section

Sponsor

Attikon Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03382938

Collaborator

(none)

100

Enrollment

Location

Arms

47.3

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Dexmedetomidine Drug: Ropivacaine Drug: Dexmedetomidine - Ropivacaine Other: 0,9% saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 23, 2019

Anticipated Primary Completion Date :

Dec 22, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Pain score [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 Outcome Measures

morphine consumption [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).
overall patient satisfaction [24 hours after the end of surgery]
overall patient satisfaction with postoperative analgesia using a 4 point scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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