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Clinical Trials/NCT04637386
NCT04637386
Completed
Not Applicable

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

Cairo University1 site in 1 country200 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstetric Pain
Sponsor
Cairo University
Enrollment
200
Locations
1
Primary Endpoint
degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
February 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ahmed nagy shaker ramadan

assistant lecture of obstetrics and gynecology

Cairo University

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/m
  • History of recent opioid exposure
  • Hypersensitivity to any of the drugs used in the study.
  • Significant cardiovascular, renal, or hepatic disease

Outcomes

Primary Outcomes

degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively

Time Frame: 24 hours

, 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 Outcomes

  • measures the time to the first postoperative opioid dose(24 hours)

Study Sites (1)

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