Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief

Not Applicable

Completed

• Conditions: Cesarean Section Pain
• Interventions: Drug: local ifiltration Bupivacaine, Meloxican and placebo

• Registration Number: NCT04538391
• Lead Sponsor: Menoufia University

Brief Summary

Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement.

Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable

Detailed Description

study type: randomized clinical trial actual enrollment: 119 allocation: Random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after Cesarean section actual study start: March 3, 2019 Primary Completion: March 5, 2020 actual study completion date: May 9, 2020

Study Timeline

• Study Start: 2019-03-03
• Primary Completion: 2020-03-05
• Study Completion: 2020-05-09
• Status Verified: 2020-08
• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-29
• Last Update Submitted: 2020-08-29
• Study First Posted: 2020-09-04
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• Age between 21-40 years
• Elective C.S at term
• Patient having no medical disorders
• Patient with no obstetrical complications

Exclusion Criteria

• extreme of reproductive age
• allergy to local anesthetic infiltration agent
• any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia
• refusal to participate in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine group	local ifiltration Bupivacaine, Meloxican and placebo	included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline.
meloxicam group	local ifiltration Bupivacaine, Meloxican and placebo	included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline.
placebo group	local ifiltration Bupivacaine, Meloxican and placebo	included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.

Primary Outcome Measures

Name	Time	Method
Postoperative analgesic requirements	immediately after the intervention	Assessment of Postoperative analgesic requirements
time of first dose of analgesia	immediately after the intervention	Determination of time of first dose of analgesia
Postoperative pain scores	immediately after the intervention	Assessment of pain scores after Cesarean section

Secondary Outcome Measures

Name	Time	Method
Postoperative fever	immediately after the intervention	Assessment of Postoperative fever
side effects of medications	immediately after the intervention	Assessment of side effects of medications
onset of mobilization	immediately after the intervention	Assessment of onset of mobilization
Pain assessment by visual analogue scale	immediately after the intervention	Post-operative pain assessment was done using a 10-point visual analogue scale

Trial Locations

Locations (1)

Menoufia University hospital; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt