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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Obstetric Pain, Obstetric Anesthesia Problems

Intervention / Treatment
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* Procedure: Transversus Abdominis Plane Block
* Procedure: Local anesthetic wound infiltration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP block group<br>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<br>* 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.<br>|
| Active Comparator: LAWI group<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transversus abdominis plane, VAS; visual analogue score, wound infiltration, cesarean section, postoperative pain, analgesia