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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04874168

Collaborator

(none)

210

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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

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

Other Names:

wound infiltration

Placebo Comparator: In placebo group (Group C )

routine analgesic was administered and recorded .

Device: TAP block

Other Names:

wound infiltration

Outcome Measures

Primary Outcome Measures

The degree of pain at rest ; [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

The time to the first postoperative opioid dose [at 2, 4, 6, and 12 hours.]
cumulative opioid consumption

Other Outcome Measures

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

Criteria

Ages Eligible for Study:

19 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	Alabbasia	Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

Feb 15, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 15, 2022