Efficacy of Hyaluronidase Added to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block in Percutaneous Nephrolithotomy.

NCT07102771 | Completed

• 1 other identifier: MS-186-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the postoperative pain via numeric rating scale (NRS) through erector spinae plane block (ESPB) by adding hyaluronidase as an adjuvant to bupivacaine on the postoperative analgesia in erector spinae plane block.

Conditions

Erector Spinae Plane Block, Nephrolithotomy, Hyaluronidase

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score by numeric rating scale (NRS)

  Pain intensity will be estimated by a numeric rating scale (NRS) (0 = no pain, 10 = worst imaginable pain)

  Started measuring on admission to PACU ( 0 time) and 2, 4, 6 and 24 hours following admission

Study Arms (2)

Group 1: ESPN with bupivacain 0.25%

ACTIVE COMPARATOR

ESPN with (30 ml volume : 15 ml saline Plus 15 ml plain bupivacaine ) .

Procedure: Ultrasound guided erector spinae plane block

Group II : ESPN with bupivacaine 0.25 % and hyalurinidase

ACTIVE COMPARATOR

ESPN with ( 14 ml saline \& 15 ml plain bupivacaine 0.25% Plus 150 units of hyaluronidase which is equal 1 ml ) .

Procedure: Ultrasound guided erector spinae plane block

Interventions

Ultrasound guided erector spinae plane block PROCEDURE

ESP block is most often performed using an in-plane ultrasound-guided technique. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves

Group 1: ESPN with bupivacain 0.25%; Group II : ESPN with bupivacaine 0.25 % and hyalurinidase

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective percutaneous nephrolithotomy
• Age: adult patients between 20 - 65 years old.
• Gender: Both male and female.
• ASA Class: I and II.

You may not qualify if:

• Refusal of patient.
• Patients ASA class III and IV.
• Chronic kidney disease grade lll \& lV .
• Pregnancy and lactation.
• Allergy to any of the study medications.
• Addicts and drug abusers.
• Patients taking corticosteroids or any cardio - active drugs.
• Severe coagulopathy ( INR \>3 or platelets \<70\*10) .
• Fever or sepsis.
• Local infection at site of the injection.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospitals

Cairo, Cairo Governorate, 1234, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Critical Care and Pain Management

Model Details: Controlled arm and interventional arm

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 5, 2025
• Study Start: January 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

EG (1)