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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-02-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group H1

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.

Group Type EXPERIMENTAL

Hyaluronidase

Intervention Type DRUG

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

Group H2

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.

Group Type EXPERIMENTAL

Hyaluronidase

Intervention Type DRUG

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

Group C

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.

Group Type PLACEBO_COMPARATOR

Bupivacaine Injection

Intervention Type DRUG

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

Interventions

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Hyaluronidase

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

Intervention Type DRUG

Bupivacaine Injection

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No