TAP Block vs LAWI for Analgesia Post-cesarean Section

NCT05447455 | Completed

• 1 other identifier: AN2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Obstetric Pain; Obstetric Anesthesia Problems

Keywords

transversus abdominis plane. VAS; visual analogue score; wound infiltration; cesarean section; postoperative pain; analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• measures the time to the first postoperative opioid dose

  24 hours

• cumulative opioid consumption at 2, 4, 6, and 12 hours.

  12 hours

Study Arms (2)

TAP block group

ACTIVE COMPARATOR

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

LAWI group

ACTIVE COMPARATOR

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

Interventions

Transversus Abdominis Plane Block PROCEDURE

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.

TAP block group

Local anesthetic wound infiltration PROCEDURE

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

LAWI group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, 11562, Egypt

Location

MeSH Terms

Conditions

Labor Pain; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Mohammed A Taymour, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 31, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

EG (1)