Back to resultsBupivacaine Verus Pethidine for Post Cesarean Section Pain Relief
Primary Purpose
Obstetric Pain
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Wound infiltration by Bupivacaine
Wound infiltration by Pethidine
Sponsored by
About this trial
This is an interventional treatment trial for Obstetric Pain
Eligibility Criteria
Inclusion Criteria:
- Mode of delivery: Cesarean section.
- Gestational age: 37-40 weeks.
- Type of anaesthesia: Spinal anaesthesia.
- No past history of any medical disorder or other medical complications during pregnancy.
Exclusion Criteria:
- Women with known hypersensitivity to bupivacaine or pethidine.
- Women delivered vaginally.
- Women delivered under general anaesthesia.
- Women with known neurological or psychological disease.
Sites / Locations
- Ain SHams Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bupivacaine Group
Pethidine Group
Arm Description
Patients delivered by cesarean section followed by wound infiltration by bupivacaine.
Patients delivered by cesarean section followed by wound infiltration by pethidine.
Outcomes
Primary Outcome Measures
Postoperative wound pain: VAS
Postoperative wound pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Mean values will be calculated and compared between the three groups
Secondary Outcome Measures
Total dose of opioid drugs needed
Total dose of extra opioid drugs needed to achieve postoperative analgesia
Incidence of nausea and vomiting
Number of patients experiencing nausea and vomiting
Incidence of urine retention
Number of patients experiencing urinary retention
Incidence of hypotension
Number of patients experiencing hypotension
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03652116
Brief Title
Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief
Official Title
Subrectal and Subcutaneous Wound Infiltration With Bupivacaine Versus Pethidine for Postcesarean Section Pain Relief: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 21, 2017 (Actual)
Primary Completion Date
June 10, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to local infiltration of cesarean section wound with either bupivacaine or pethidine; with follow up of postoperative pain relief.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine Group
Arm Type
Active Comparator
Arm Description
Patients delivered by cesarean section followed by wound infiltration by bupivacaine.
Arm Title
Pethidine Group
Arm Type
Active Comparator
Arm Description
Patients delivered by cesarean section followed by wound infiltration by pethidine.
Intervention Type
Drug
Intervention Name(s)
Wound infiltration by Bupivacaine
Intervention Description
Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound
Intervention Type
Drug
Intervention Name(s)
Wound infiltration by Pethidine
Intervention Description
Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound
Primary Outcome Measure Information:
Title
Postoperative wound pain: VAS
Description
Postoperative wound pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Mean values will be calculated and compared between the three groups
Time Frame
first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Total dose of opioid drugs needed
Description
Total dose of extra opioid drugs needed to achieve postoperative analgesia
Time Frame
first 24 hours postoperatively
Title
Incidence of nausea and vomiting
Description
Number of patients experiencing nausea and vomiting
Time Frame
first 24 hours postoperatively
Title
Incidence of urine retention
Description
Number of patients experiencing urinary retention
Time Frame
first 24 hours postoperatively
Title
Incidence of hypotension
Description
Number of patients experiencing hypotension
Time Frame
first 24 hours postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mode of delivery: Cesarean section.
Gestational age: 37-40 weeks.
Type of anaesthesia: Spinal anaesthesia.
No past history of any medical disorder or other medical complications during pregnancy.
Exclusion Criteria:
Women with known hypersensitivity to bupivacaine or pethidine.
Women delivered vaginally.
Women delivered under general anaesthesia.
Women with known neurological or psychological disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Samy, MD
Organizational Affiliation
M Samy
Official's Role
Study Director
Facility Information:
Facility Name
Ain SHams Maternity Hospital
City
Cairo
State/Province
Abbaseya
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief
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