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

Bupivacaine Versus Meloxicam Infiltration 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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Pain
• Intervention / Treatment: Drug: local ifiltration Bupivacaine, Meloxican and placebo

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

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 11111
      • Menoufia university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: local ifiltration Bupivacaine, Meloxican and placebo; no other intervention done
Active Comparator: 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.	Drug: local ifiltration Bupivacaine, Meloxican and placebo; no other intervention done
Active Comparator: placebo group; included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.	Drug: local ifiltration Bupivacaine, Meloxican and placebo; no other intervention done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative fever	Assessment of Postoperative fever	immediately after the intervention
onset of mobilization	Assessment of onset of mobilization	immediately after the intervention
side effects of medications	Assessment of side effects of medications	immediately after the intervention
Pain assessment by visual analogue scale	Post-operative pain assessment was done using a 10-point visual analogue scale	immediately after the intervention

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Mohamed E Anter, MD, Menoufia university hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2019
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): May 9, 2020

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 29, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: August 29, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 12/2019OBSGN38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: through the E-maill address

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No