Clinical trial NCT04538391: Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief
Official title: Bupivacaine Versus Meloxicam Infiltration on Post Cesarean Section Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 105
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain scores
timeFrame: immediately after the intervention
measure: Postoperative analgesic requirements
timeFrame: immediately after the intervention
measure: time of first dose of analgesia
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Postoperative fever
timeFrame: immediately after the intervention
measure: onset of mobilization
timeFrame: immediately after the intervention
measure: side effects of medications
timeFrame: immediately after the intervention
measure: Pain assessment by visual analogue scale
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University hospital
state: Menoufia
Study officials:
affiliation: Menoufia University hospital
name: Mohamed E Anter, MD
role: PRINCIPAL_INVESTIGATOR
References: