Back to resultsTAP Block vs LAWI for Analgesia Post-cesarean Section: RCT
Primary Purpose
Obstetric Pain, Obstetric Anesthesia Problems
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transversus Abdominis Plane Block
Local anesthetic wound infiltration
Sponsored by
About this trial
This is an interventional supportive care trial for Obstetric Pain focused on measuring transversus abdominis plane, VAS; visual analogue score, wound infiltration, cesarean section, postoperative pain, analgesia
Eligibility Criteria
Inclusion Criteria:
- Women who underwent cesarean section under spinal anesthesia.
- Aged ≥19 years and less than 40 years.
- Gestational age ≥ 37 Weeks.
Exclusion Criteria:
- Body mass index (BMI) ≥40 kg/m2.
- History of recent opioid exposure
- Hypersensitivity to any of the drugs used in the study.
- Significant cardiovascular, renal, or hepatic disease
Sites / Locations
- faculty of medicine - Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TAP block group
LAWI group
Arm Description
A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.
40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure
Outcomes
Primary Outcome Measures
degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively
, using a visual analog scale (VAS) score for pain intensity reported on 0-10-point scale for analysis. (0 = no pain and 10 = the worst possible pain).
Secondary Outcome Measures
measures the time to the first postoperative opioid dose
time interval from postoperative till first dose of opioid
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04637386
Brief Title
TAP Block vs LAWI for Analgesia Post-cesarean Section: RCT
Official Title
the Efficacy of Transversus Abdominis Plane Block for Analgesia in Comparison With Local Anesthetic Wound Infiltration Post-cesarean Section: A Randomized Comparative Double-blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Pain, Obstetric Anesthesia Problems
Keywords
transversus abdominis plane, VAS; visual analogue score, wound infiltration, cesarean section, postoperative pain, analgesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAP block group
Arm Type
Active Comparator
Arm Description
A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.
Arm Title
LAWI group
Arm Type
Active Comparator
Arm Description
40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane Block
Intervention Description
A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.
Intervention Type
Procedure
Intervention Name(s)
Local anesthetic wound infiltration
Intervention Description
40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure
Primary Outcome Measure Information:
Title
degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively
Description
, using a visual analog scale (VAS) score for pain intensity reported on 0-10-point scale for analysis. (0 = no pain and 10 = the worst possible pain).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
measures the time to the first postoperative opioid dose
Description
time interval from postoperative till first dose of opioid
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who underwent cesarean section under spinal anesthesia.
Aged ≥19 years and less than 40 years.
Gestational age ≥ 37 Weeks.
Exclusion Criteria:
Body mass index (BMI) ≥40 kg/m2.
History of recent opioid exposure
Hypersensitivity to any of the drugs used in the study.
Significant cardiovascular, renal, or hepatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Taymour, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine - Cairo university
City
Cairo
State/Province
Kasr El Ainy
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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TAP Block vs LAWI for Analgesia Post-cesarean Section: RCT
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