CClinicalTrials.gg
Status unknownNCT04874168TAPBLOCKUpdated Feb 15, 2022

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

An interventional study of TAP block in Cesarean Section Complications, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 19 Years to 39 Years. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2021, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
19 Years to 39 Years
Sex
Female
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Study 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

Read the 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 .

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Conditions studied

  • Cesarean Section Complications
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In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Active comparator
    In the TAP group (Group A )

    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.

    Device: TAP block

  • Active comparator
    In the infiltration group (Group B )

    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.

    Device: TAP block

  • Placebo comparator
    In placebo group (Group C )

    routine analgesic was administered and recorded .

    Device: TAP block

Interventions

  • DeviceTAP block

    bilateral ultrasound-guided TAP block was performed using 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

    Also known as: wound infiltration

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What researchers measure

Primary outcomes

  1. The degree of pain at rest ;

    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) .

    Time frame: From 2 hours to 24 hours postoperatively

Secondary outcomes

  1. The time to the first postoperative opioid dose

    cumulative opioid consumption

    Time frame: at 2, 4, 6, and 12 hours.

Other outcomes

  1. The degree of pain on movement (hip flexion and coughing)

    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) .

    Time frame: From 2 hours to 24 hours postoperatively

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04874168
Lead sponsor
Ain Shams University
Responsible party
Mohamed Hassan Mohamed Mostafa (Clinical professor, Ain Shams University) — Principal investigator
First posted
May 5, 2021
Start date
Jan 1, 2021
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Feb 15, 2022

Study contacts

Ahmed Gamal Elnajar, MD
Contact
a7medgamal2020.ag@gmail.com
0201092672757
Ahmed G Elnajar, MD
principal investigator · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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