Clinical trial

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

Name
WIWDICS
Description
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).
Trial arms
Trial start
2019-08-23
Estimated PCD
2023-12-22
Trial end
2024-02-01
Status
Recruiting
Treatment
Dexmedetomidine
WOUND INFILTRATION IN CESAREAN SECTION
Arms:
Dexmedetomidine
Other names:
Dexmed
Ropivacaine
WOUND INFILTRATION IN CESAREAN SECTION
Arms:
Ropivacaine
Other names:
Ropi
Dexmedetomidine - Ropivacaine
WOUND INFILTRATION IN CESAREAN SECTION
Arms:
Dexmedetomidine - Ropivacaine
Other names:
Dexmed Ropi
0,9% saline
placebo WOUND INFILTRATION IN CESAREAN SECTION
Arms:
0.9 % saline
Other names:
normal saline
Size
100
Primary endpoint
Pain score
up to 24 hours after the end of surgery
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double (Investigator, Outcomes Assessor)', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-07-20

1 organization

3 products

1 indication

Organization
Attikon Hospital