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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04637386

Collaborator

(none)

200

Enrollment

Location

Arms

13.5

Actual Duration (Months)

14.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Obstetric Pain Obstetric Anesthesia Problems	Procedure: Transversus Abdominis Plane Block Procedure: Local anesthetic wound infiltration	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Feb 15, 2022

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

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