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

Effect of Adding Two Different Doses of Hyaluronidase to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Post-cesarean Section Analgesia; A Randomized Controlled Double Blinded Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Hyaluronidase; Drug: Bupivacaine Injection

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samar R Amin; Phone Number: 01287793991; Email: samar.rafik@gmail.com
• Study Contact Backup: Name: Elsayed M Abdelzaam; Email: sayedzim12@yahoo.com

Study Locations

• Egypt
  • Qalubia
    • Banhā, Qalubia, Egypt, 13511
      • Recruiting
      • Samar Rafik Amin
      • Contact: Samar R. Amin, lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Hyaluronidase; hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS
Experimental: 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.	Drug: Hyaluronidase; hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS
Placebo Comparator: 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.	Drug: Bupivacaine Injection; 20ml bupivacaine will be injected without additives in the transversus abdominis plane block on each side for postoperative analgesic after CS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration of analgesia	the interval between performing the block and the time of the first request for analgesia.	24 hours postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): November 10, 2023
• Study Completion (Estimated): December 10, 2023

Study Registration Dates

• First Submitted: January 1, 2023
• First Submitted That Met QC Criteria: January 1, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: RC 4-8-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No