- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04538391
Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief
August 29, 2020 updated by: Mohamed Elsibai Anter, Menoufia University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Menoufia
-
Shibīn Al Kawm, Menoufia, Egypt, 11111
- Menoufia University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
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.
|
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.
|
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.
|
no other intervention done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain scores
Time Frame: immediately after the intervention
|
Assessment of pain scores after Cesarean section
|
immediately after the intervention
|
Postoperative analgesic requirements
Time Frame: immediately after the intervention
|
Assessment of Postoperative analgesic requirements
|
immediately after the intervention
|
time of first dose of analgesia
Time Frame: immediately after the intervention
|
Determination of time of first dose of analgesia
|
immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative fever
Time Frame: immediately after the intervention
|
Assessment of Postoperative fever
|
immediately after the intervention
|
onset of mobilization
Time Frame: immediately after the intervention
|
Assessment of onset of mobilization
|
immediately after the intervention
|
side effects of medications
Time Frame: immediately after the intervention
|
Assessment of side effects of medications
|
immediately after the intervention
|
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
|
immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed E Anter, MD, Menoufia University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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