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

Pain, Postoperative Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671172
• Other study ID #: RC 4-8-2022
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: December 10, 2023

Study information

• Verified date: July 2023
• Source: Benha University
• Contact: Samar R Amin
• Phone: 01287793991
• Email: samar.rafik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Hyaluronidase
hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS
• Bupivacaine Injection
20ml bupivacaine will be injected without additives in the transversus abdominis plane block on each side for postoperative analgesic after CS

Locations

Country	Name	City	State
Egypt	Samar Rafik Amin	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the duration of analgesia	the interval between performing the block and the time of the first request for analgesia.	24 hours postoperative
Secondary	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
Secondary	total morphine consumption		at 24 hours postoperatively
Secondary	patient satisfaction	assessed on a four-point scale (1, excellent; 2, good; 3, fair; 4, poor)	at 24 hours postoperatively