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

NCT04874168 | Unknown DMC

• 1 other identifier: tapblockvwoundInfiltration
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section Complications

Outcome Measures

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) .

  From 2 hours to 24 hours postoperatively

Secondary Outcomes (1)

• The time to the first postoperative opioid dose

  at 2, 4, 6, and 12 hours.

Other Outcomes (1)

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

  From 2 hours to 24 hours postoperatively

Study Arms (3)

In the TAP group (Group A )

ACTIVE COMPARATOR

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

In the infiltration group (Group B )

ACTIVE COMPARATOR

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

In placebo group (Group C )

PLACEBO COMPARATOR

routine analgesic was administered and recorded .

Device: TAP block

Interventions

TAP block DEVICE

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

In placebo group (Group C ); In the TAP group (Group A ); In the infiltration group (Group B )

Eligibility Criteria

• Age: 19 Years - 39 Years
• Gender Eligibility Details: Women undergoing cesarean section under spinal anesthesia .
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Alabbasia, Egypt

RECRUITING

Study Officials

• Ahmed G Elnajar, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Gamal Elnajar, MD

CONTACT

0201092672757; a7medgamal2020.ag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: computer-generated table of random numbers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 5, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)