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Not yet recruiting NCT06839391

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

Early Phase I Interventional Tab Block Qaulity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyaluronidase.
Who it may be relevant to
Registry conditions: Tab Block Qaulity. Basic parameters: 20 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • visual analogue scale [Time frame: 2-6-10-16-24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • pregnant 20-45 y medical free

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT06839391 · TAB BLOCK QAULITY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗