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

Menoufia University

Status: Completed

Conditions: Cesarean Section Pain

Treatments: Drug: local ifiltration Bupivacaine, Meloxican and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04538391

12/2019OBSGN38

Details and patient eligibility

About

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

Full 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

Enrollment: 105 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups

bupivacaine group

Active Comparator group

Description:

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.

Treatment:

Drug: local ifiltration Bupivacaine, Meloxican and placebo

meloxicam group

Active Comparator group

Description:

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.

Treatment:

Drug: local ifiltration Bupivacaine, Meloxican and placebo

placebo group

Active Comparator group

Description:

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

Treatment:

Drug: local ifiltration Bupivacaine, Meloxican and placebo