Completed

NCT Number: NCT05447455

TAP Block vs LAWI for Analgesia Post-cesarean Section

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

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Key information

Conditions

Obstetric Pain Agnosia Labor Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstetric Anesthesia Problems Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/m2.
History of recent opioid exposure
Hypersensitivity to any of the drugs used in the study.
Significant cardiovascular, renal, or hepatic disease

Treatment and study plan

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.

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

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

Time frame: 24 hours
cumulative opioid consumption at 2, 4, 6, and 12 hours.

Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 7, 2022
Registry last updated: Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed