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

Not Applicable

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Drug: Bupivacaine Injection; Drug: Hyaluronidase

• Registration Number: NCT05671172
• Lead Sponsor: Benha University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-15
• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-01
• Study First Posted: 2023-01-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-11-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Bupivacaine Injection	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 H1	Hyaluronidase	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 H2	Hyaluronidase	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.

Primary Outcome Measures

Name	Time	Method
the duration of analgesia	24 hours postoperative	the interval between performing the block and the time of the first request for analgesia.

Secondary Outcome Measures

Name	Time	Method
the postoperative pain severity	every 0,2,4,8,12, up to 24 hours postoperative	pain was assessed by the visual analog scale (VAS) pain score (range, 0-10; 0, no pain; 10, worst pain)
patient satisfaction	at 24 hours postoperatively	assessed on a four-point scale (1, excellent; 2, good; 3, fair; 4, poor)
total morphine consumption	at 24 hours postoperatively

Trial Locations

Locations (1)

Samar Rafik Amin; 🇪🇬 Banhā, Qalubia, Egypt