TAP Block vs LAWI for Analgesia Post-cesarean Section: RCT

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

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

Study Overview

• Status: Completed
• Conditions: Obstetric Pain; Obstetric Anesthesia Problems
• Intervention / Treatment: Procedure: Transversus Abdominis Plane Block; Procedure: Local anesthetic wound infiltration

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kasr El Ainy
    • Cairo, Kasr El Ainy, Egypt, 11562
      • Faculty of Medicine - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women who underwent cesarean section under spinal anesthesia.
2. Aged ≥19 years and less than 40 years.
3. Gestational age ≥ 37 Weeks.

Exclusion Criteria:

1. Body mass index (BMI) ≥40 kg/m2.
2. History of recent opioid exposure
3. Hypersensitivity to any of the drugs used in the study.
4. Significant cardiovascular, renal, or hepatic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TAP block group; 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.	Procedure: Transversus Abdominis Plane Block; 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.
ACTIVE_COMPARATOR: LAWI group; 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	Procedure: Local anesthetic wound infiltration; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measures the time to the first postoperative opioid dose	time interval from postoperative till first dose of opioid	24 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): January 30, 2022
• Study Completion (ACTUAL): February 15, 2022

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 15, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: cesarean section; analgesia; postoperative pain; wound infiltration; transversus abdominis plane; VAS; visual analogue score
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: MD-300-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No