Effect of Hyaluronidase in Different Doses Added to Bupivacaine on TAB Block Quality During CS

NCT06839391 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: TAB BLOCK QAULITY
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS

Conditions

Tab Block Qaulity

Keywords

hyaluronidase-bupivacaine-TAB block

Outcome Measures

Primary Outcomes (1)

• visual analogue scale

  postoperatively pain assesment

  2-6-10-16-24 hours postoperatively

Study Arms (3)

group I

EXPERIMENTAL

After skin closure, they got TAB block with 20 cc of 0.25 percent bupivacaine on each side without any adjuvant.

Drug: Hyaluronidase

group II

EXPERIMENTAL

obtained After the skin was closed, we received TAB block with 20 ml of 0.25% bupivacaine and 5 ml of 0.9% normal saline containing 500 IU (100 IU/ml) of hyaluronidase (Hynidase) as an adjuvant on each side.

Drug: Hyaluronidase

GROUP III

EXPERIMENTAL

obtained After the skin was closed, we received TAB block with 20 ml of 0.25% bupivacaine and 5 ml of 0.9% normal saline containing 1000 IU (200 IU/ml) hyaluronidase (Hynidase) as an adjuvant on each side.

Drug: Hyaluronidase

Interventions

Hyaluronidase DRUG

Effect of hyaluronidases in different doses added to bupivacaine on quality of ultrasound-guided TAB block during CS ,

GROUP III; group I; group II

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant 20-45 y medical free

You may not qualify if:

• Hepatic.
• Renal.
• Diabetic.
• Hypertensive.
• Cardiovascular dysfunction.

Sponsors & Collaborators

• Benha University: lead

Related Publications (3)

• Keeler JF, Simpson KH, Ellis FR, Kay SP. Effect of addition of hyaluronidase to bupivacaine during axillary brachial plexus block. Br J Anaesth. 1992 Jan;68(1):68-71. doi: 10.1093/bja/68.1.68.

  PMID: 1739571 BACKGROUND

• Koh WU, Min HG, Park HS, Karm MH, Lee KK, Yang HS, Ro YJ. Use of hyaluronidase as an adjuvant to ropivacaine to reduce axillary brachial plexus block onset time: a prospective, randomised controlled study. Anaesthesia. 2015 Mar;70(3):282-9. doi: 10.1111/anae.12879. Epub 2014 Oct 28.

  PMID: 25347936 BACKGROUND

• Kumar CM, Macachor J. Hyaluronidase for brachial plexus block. Anaesthesia. 2015 Sep;70(9):1097-8. doi: 10.1111/anae.13186. No abstract available.

  PMID: 26263864 BACKGROUND

MeSH Terms

Interventions

Hyaluronoglucosaminidase

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesia lecturer

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02