Effect of Adding Hyaluronidase to Bupivacaine in Transversus Abdominis Plane Block for Cesarean Section

NCT05671172 | Completed

• 1 other identifier: RC 4-8-2022
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Since TAP block needs to affect several nerves in single tissue plane with a single prick, hyaluronidase is expected to aid greatly in the spread of the LA and help the block. However, there have not been adequate studies to establish the efficacy of adding hyaluronidase in lateral TAP after cesarean section. Hence, the present study was carried out to evaluate the efficacy of hyaluronidase in different concentrations added to bupivacaine in US-guided bilateral lateral TAP block.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• the duration of analgesia

  the interval between performing the block and the time of the first request for analgesia.

  24 hours postoperative

Secondary Outcomes (3)

• the postoperative pain severity

  every 0,2,4,8,12, up to 24 hours postoperative

• total morphine consumption

  at 24 hours postoperatively

• patient satisfaction

  at 24 hours postoperatively

Study Arms (3)

Group H1

EXPERIMENTAL

patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline containing 750 IU hyaluronidase as an adjuvant in each side after closing skin.

Drug: Hyaluronidase

Group H2

EXPERIMENTAL

patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline containing 1500 IU hyaluronidase as an adjuvant in each side after closing skin.

Drug: Hyaluronidase

Group C

PLACEBO COMPARATOR

patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline without any adjuvant in each side after closing skin.

Drug: Bupivacaine Injection

Interventions

Hyaluronidase DRUG

hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS

Group H1; Group H2

Bupivacaine Injection DRUG

20ml bupivacaine will be injected without additives in the transversus abdominis plane block on each side for postoperative analgesic after CS

Group C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• parturients who aged between 18-40 years old
• with ASA physical status grade II and
• scheduled for elective CS under spinal anesthesia

You may not qualify if:

• patients with ASA grade III or IV,
• refusal to participate,
• emergency CS or complicated pregnancy,
• those with bleeding disorders or on anticoagulants,
• those with severe respiratory and cardiovascular diseases,
• having any local infection at the injection site,
• history of allergy to one of the used drugs,
• obese patients (body mass index ≥ 30 kg/m2).

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hyaluronoglucosaminidase; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: January 4, 2023
• Study Start: May 15, 2023
• Primary Completion: January 10, 2024
• Study Completion: February 10, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)