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

Study Overview
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Brief Summary
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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
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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

Official Title
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Bupivacaine Versus Meloxicam Infiltration on Post Cesarean Section Pain Relief

Conditions
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Cesarean Section Pain

Intervention / Treatment
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* Drug: local ifiltration Bupivacaine, Meloxican and placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A (bupivacaine group): 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. Group B (meloxicam group): 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. Group C (placebo group): included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine group<br>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. | Drug: local ifiltration Bupivacaine, Meloxican and placebo<br>* no other intervention done<br>|
| Active Comparator: meloxicam group<br>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. | Drug: local ifiltration Bupivacaine, Meloxican and placebo<br>* no other intervention done<br>|
| Active Comparator: placebo group<br>included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline. | Drug: local ifiltration Bupivacaine, Meloxican and placebo<br>* no other intervention done<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores | Assessment of pain scores after Cesarean section | immediately after the intervention | 
| Postoperative analgesic requirements | Assessment of Postoperative analgesic requirements | immediately after the intervention | 
| time of first dose of analgesia | Determination of time of first dose of analgesia | immediately after the intervention | 

Secondary Outcome Measures

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