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

February 14, 2022 updated by: Mohamed Hassan Mohamed Mostafa, Ain Shams University

The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (A Randomized Controlled Double-blinded Clinical Trial )

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Alabbasia
      • Cairo, Alabbasia, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other Names:
  • wound infiltration
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
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
Other Names:
  • wound infiltration
PLACEBO_COMPARATOR: In placebo group (Group C )
routine analgesic was administered and recorded .
Device: TAP 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
Other Names:
  • wound infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of pain at rest ;
Time Frame: 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) .
From 2 hours to 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to the first postoperative opioid dose
Time Frame: at 2, 4, 6, and 12 hours.
cumulative opioid consumption
at 2, 4, 6, and 12 hours.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of pain on movement (hip flexion and coughing)
Time Frame: 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) .
From 2 hours to 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed G Elnajar, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

June 30, 2022

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

May 1, 2021

First Posted (ACTUAL)

May 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • tapblockvwoundInfiltration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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