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

A

Ain Shams University

Status

Unknown

Conditions

Cesarean Section Complications

Treatments

Device: TAP block

Study type

Interventional

Funder types

Other

Identifiers

NCT04874168
tapblockvwoundInfiltration

Details and patient eligibility

About

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

Full 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 .

Enrollment

210 estimated patients

Sex

Female

Ages

19 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

210 participants in 3 patient groups, including a placebo group

In the TAP group (Group A )
Active Comparator group
Description:
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.
Treatment:
Device: TAP block
In the infiltration group (Group B )
Active Comparator group
Description:
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.
Treatment:
Device: TAP block
In placebo group (Group C )
Placebo Comparator group
Description:
routine analgesic was administered and recorded .
Treatment:
Device: TAP block

Trial contacts and locations

1

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Central trial contact

Ahmed Gamal Elnajar, MD

Data sourced from clinicaltrials.gov

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