The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery:

Not Applicable

• Conditions: Cesarean Section Complications
• Interventions: Device: TAP block

• Registration Number: NCT04874168
• Lead Sponsor: Ain Shams University

Brief Summary

This study aimed to compare bilateral ultrasound-guided TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia

Detailed Description

This double-blind, randomized controlled trial aimed to compare bilateral ultrasound-guided TAP block to single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. This will be done by measuring VAS (visual analogue score) for pain after ceserian section at2, 4, 6, 12, 24 hours .

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• Women undergoing cesarean section under spinal anesthesia
• Aged ≥19 years and > 40 years .
• Gestational age ≥ 37 Weeks .
• Informed Consent From the Patient .

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In placebo group (Group C )	TAP block	routine analgesic was administered and recorded .
In the TAP group (Group A )	TAP block	after completion of surgery, bilateral ultrasound-guided TAP block was performed . Description of the intervention: a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used ;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.
In the infiltration group (Group B )	TAP block	at the end of surgery, 40 mL of bupivacaine 0.25% was injected subcutaneously in the surgical wound (20 mL in each of the upper and lower sides) by the obstetrician before skin closure.

Primary Outcome Measures

Name	Time	Method
The degree of pain at rest ;	From 2 hours to 24 hours postoperatively	using an Visual analogue scale (VAS) scores for pain intensity reported on 0-10 point scale for analysis. (0 = no pain and 10 = the worst possible pain) .

Secondary Outcome Measures

Name	Time	Method
The time to the first postoperative opioid dose	at 2, 4, 6, and 12 hours.	cumulative opioid consumption

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Alabbasia, Egypt