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

B

Benha University

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Tab Block Qaulity

Treatments

Drug: Hyaluronidase

Study type

Interventional

Funder types

Other

Identifiers

NCT06839391
TAB BLOCK QAULITY

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • pregnant 20-45 y medical free

Exclusion criteria

  • • Hepatic.

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 3 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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