TAP Block vs LAWI for Analgesia Post-cesarean Section

NCT ID: NCT05447455

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Transversus Abdominis Plane Block

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Local anesthetic wound infiltration

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

ahmed nagy shaker ramadan

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A Taymour, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, Egypt

Countries

Egypt

Other Identifiers

AN2022

Identifier Type: -

Identifier Source: org_study_id