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

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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