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

Cesarean Section Pain Clinical Trial

Official title:

Bupivacaine Versus Meloxicam Infiltration on Post Cesarean Section Pain Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538391
• Other study ID #: 12/2019OBSGN38
• Status: Completed
• Phase: N/A
• Start date: March 3, 2019
• Est. completion date: May 9, 2020

Study information

• Verified date: August 2020
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 9, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Pain

Intervention

Drug:
• local ifiltration Bupivacaine, Meloxican and placebo
no other intervention done

Locations

Country	Name	City	State
Egypt	Menoufia University hospital	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores	Assessment of pain scores after Cesarean section	immediately after the intervention
Primary	Postoperative analgesic requirements	Assessment of Postoperative analgesic requirements	immediately after the intervention
Primary	time of first dose of analgesia	Determination of time of first dose of analgesia	immediately after the intervention
Secondary	Postoperative fever	Assessment of Postoperative fever	immediately after the intervention
Secondary	onset of mobilization	Assessment of onset of mobilization	immediately after the intervention
Secondary	side effects of medications	Assessment of side effects of medications	immediately after the intervention
Secondary	Pain assessment by visual analogue scale	Post-operative pain assessment was done using a 10-point visual analogue scale	immediately after the intervention