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

NCT ID: NCT04874168

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-06-30

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

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 .

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TAP block

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

TAP block

Intervention Type: 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

In placebo group (Group C )

routine analgesic was administered and recorded .

Group Type: PLACEBO_COMPARATOR

TAP block

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

wound infiltration

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Hassan Mohamed Mostafa

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed G Elnajar, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, Alabbasia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Gamal Elnajar, MD

Role: CONTACT

a7medgamal2020.ag@gmail.com

0201092672757

Facility Contacts

ahmed G elnajar, md

Role: primary

a7medgamal2020.ag@gmail.com

0201092672757

Other Identifiers

tapblockvwoundInfiltration

Identifier Type: -

Identifier Source: org_study_id