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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03382938
Other study ID # WIWDICS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 23, 2019
Est. completion date February 2024

Study information

Verified date July 2023
Source Attikon Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 2024
Est. primary completion date December 22, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
WOUND INFILTRATION IN CESAREAN SECTION
Ropivacaine
WOUND INFILTRATION IN CESAREAN SECTION
Dexmedetomidine - Ropivacaine
WOUND INFILTRATION IN CESAREAN SECTION
Other:
0,9% saline
placebo WOUND INFILTRATION IN CESAREAN SECTION

Locations

Country Name City State
Greece Paraskevi K Matsota Athens Other

Sponsors (1)

Lead Sponsor Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary overall patient satisfaction overall patient satisfaction with postoperative analgesia using a 4 point scale 24 hours after the end of surgery
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