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

Cesarean Section Complications Clinical Trial

— TAPBLOCK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04874168
• Other study ID #: tapblockvwoundInfiltration
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2022
• Source: Ain Shams University
• Contact: Ahmed Gamal Elnajar, MD
• Phone: 0201092672757
• Email: a7medgamal2020.ag[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Alabbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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) .	From 2 hours to 24 hours postoperatively
Primary	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	The time to the first postoperative opioid dose	cumulative opioid consumption	at 2, 4, 6, and 12 hours.