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

NCT04538391 | Completed DMC

• 1 other identifier: 12/2019OBSGN38
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Postoperative fever

  immediately after the intervention

• onset of mobilization

  immediately after the intervention

• side effects of medications

  immediately after the intervention

• Pain assessment by visual analogue scale

  immediately after the intervention

Study Arms (3)

bupivacaine group

ACTIVE COMPARATOR

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

meloxicam group

ACTIVE COMPARATOR

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

placebo group

ACTIVE COMPARATOR

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

Drug: local ifiltration Bupivacaine, Meloxican and placebo

Interventions

local ifiltration Bupivacaine, Meloxican and placebo DRUG

no other intervention done

bupivacaine group; meloxicam group; placebo group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 21-40 years
• Elective C.S at term
• Patient having no medical disorders
• Patient with no obstetrical complications

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

Location

Study Officials

• Mohamed E Anter, MD

  Menoufia University hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 4, 2020
• Study Start: March 3, 2019
• Primary Completion: March 5, 2020
• Study Completion: May 9, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)