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Completed

NCT Number: NCT04538391

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

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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Key information

Conditions

Cesarean Section Pain

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

local ifiltration Bupivacaine, Meloxican and placebo

Drug

no other intervention done

Primary outcomes

  1. Postoperative pain scores

    Time frame: immediately after the intervention

    Assessment of pain scores after Cesarean section

  2. Postoperative analgesic requirements

    Time frame: immediately after the intervention

    Assessment of Postoperative analgesic requirements

  3. time of first dose of analgesia

    Time frame: immediately after the intervention

    Determination of time of first dose of analgesia

Secondary outcomes

  1. Postoperative fever

    Time frame: immediately after the intervention

    Assessment of Postoperative fever

  2. onset of mobilization

    Time frame: immediately after the intervention

    Assessment of onset of mobilization

  3. side effects of medications

    Time frame: immediately after the intervention

    Assessment of side effects of medications

  4. Pain assessment by visual analogue scale

    Time frame: immediately after the intervention

    Post-operative pain assessment was done using a 10-point visual analogue scale

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Bupivacaine Versus Meloxicam Infiltration on Post Cesarean Section Pain Relief

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2020
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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