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

Early Phase 1

Not yet recruiting

• Conditions: Tab Block Qaulity
• Interventions: Drug: Hyaluronidase

• Registration Number: NCT06839391
• Lead Sponsor: Benha University

Brief Summary

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

Detailed Description

Hyaluronidase acts by catalyzing the hydrolysis of hyaluronan, decreased its viscosity, and enchasing the tissue permeability. So, this makes it a suitable additive for other drugs to speed up their distribution and delivery especially in ophthalmic surgery. Several studies showed that multiple injection techniques of TAB block were more successful with a faster onset of anesthesia and higher success rates, with a change in the incidence of complications.

This double-blinded randomized prospective study was conducted to evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS . The primary outcome of this study was the duration of sensory block, while secondary outcomes included the onset of sensory block, success rate, total doses of intraoperative rescue analgesia, number of patients needed for postoperative rescue analgesia, and complications.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Study Start: 2025-03
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• pregnant 20-45 y medical free

Exclusion Criteria

• • Hepatic.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I	Hyaluronidase	After skin closure, they got TAB block with 20 cc of 0.25 percent bupivacaine on each side without any adjuvant.
group II	Hyaluronidase	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.
GROUP III	Hyaluronidase	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.

Primary Outcome Measures

Name	Time	Method
visual analogue scale	2-6-10-16-24 hours postoperatively	postoperatively pain assesment