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

Benha University

Status: Completed

Conditions: Pain, Postoperative

Treatments: Drug: Hyaluronidase; Drug: Bupivacaine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05671172

RC 4-8-2022

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups, including a placebo group

Group H1

Experimental group

Description:

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.

Treatment:

Drug: Hyaluronidase

Group H2

Experimental group

Description:

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.

Treatment:

Drug: Hyaluronidase

Group C

Placebo Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine Injection