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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-03

Study Completion Date

2020-05-09

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

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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

Conditions

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Cesarean Section Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Each woman received a disposable syringe containing a medication corresponding to her order of participation in the trial. Packing. Sealing and numbering were performed by health care provider who did not actively share in the process of the study.

Study Groups

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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 Type ACTIVE_COMPARATOR

local ifiltration Bupivacaine, Meloxican and placebo

Intervention Type DRUG

no other intervention done

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 Type ACTIVE_COMPARATOR

local ifiltration Bupivacaine, Meloxican and placebo

Intervention Type DRUG

no other intervention done

placebo group

included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.

Group Type ACTIVE_COMPARATOR

local ifiltration Bupivacaine, Meloxican and placebo

Intervention Type DRUG

no other intervention done

Interventions

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local ifiltration Bupivacaine, Meloxican and placebo

no other intervention done

Intervention Type DRUG

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes