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

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ClinicalTrials.gov Identifier: NCT04874168
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Mohamed Hassan Mohamed Mostafa, Ain Shams University

Study Description
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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

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Device: TAP block Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: computer-generated table of random numbers
Primary Purpose: Treatment
Official Title: The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (A Randomized Controlled Double-blinded Clinical Trial )
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: wound infiltration


Outcome Measures
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Primary Outcome Measures :
  1. 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) .


Secondary Outcome Measures :
  1. The time to the first postoperative opioid dose [ Time Frame: at 2, 4, 6, and 12 hours. ]
    cumulative opioid consumption


Other Outcome Measures:
  1. 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) .


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women undergoing cesarean section under spinal anesthesia .
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874168


Contacts
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Contact: Ahmed Gamal Elnajar, MD 0201092672757 a7medgamal2020.ag@gmail.com

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Alabbasia, Egypt
Contact: ahmed G elnajar, md    0201092672757    a7medgamal2020.ag@gmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ahmed G Elnajar, MD Ain Shams University
More Information
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Responsible Party: Mohamed Hassan Mohamed Mostafa, Clinical professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04874168    
Other Study ID Numbers: tapblockvwoundInfiltration
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No