ISB, SSNB, and PENG Block for Arthroscopic Shoulder Surgery

NCT05739201 | Unknown

• 1 other identifier: 36264MS18/1/23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate the post-operative analgesic effect of interscalene nerve block or anterior suprascapular nerve block compared to pericapsular nerve group block in patient undergoing elective arthroscopic shoulder surgery.

Conditions

Interscalene Nerve Block; Anterior Suprascapular Nerve Block; Arthroscopic Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• the total opioid consumption.

  Postoperative analgesia will be assessed by total opioid consumption and time till administration of first rescue analgesia will be recorded.

  24-hour postoperatively

Study Arms (3)

Group (I)

ACTIVE COMPARATOR

30 patients will receive interscalene nerve block.

Procedure: interscalene nerve block

Group (II)

ACTIVE COMPARATOR

30 Patients will receive anterior suprascapular nerve block.

Procedure: anterior suprascapular nerve block

Group (III)

ACTIVE COMPARATOR

30 atients will receive pericapsular nerve group block around shoulder surgery

Procedure: Peri-capsular nerve group block

Interventions

interscalene nerve block PROCEDURE

Patients will receive interscalene nerve block, in which the patient will be in supine position with the head turned to the contralateral side using an ultrasound scan to identify the C5 and C6 nerve roots between the scalene muscles.15 ml of 0.25% Bupivacaine will be deposited between the C5 and C6 nerve roots, within the interscalene groove using a 22 gauge-regional block needle.

Group (I)

anterior suprascapular nerve block PROCEDURE

Patients will receive anterior suprascapular nerve block, in which the patient will be in supine position with the head turned to the contralateral side, using an ultrasound the nerve will be traced as it diverges from the brachial plexus to lie under the omohyoid muscle in the supraclavicular fossa. 15 ml of 0.25% Bupivacaine will be deposited lateral to the suprascapular nerve, underneath the omohyoid muscle using a 22 gauge-regional block needle.

Group (II)

Peri-capsular nerve group block PROCEDURE

Patients will receive PENG block, in which the patient will be in supine position and the patient's arm will be placed in external rotation and abducted at 45 degrees, using an ultrasound the humeral head, the tendon of the subscapularis muscle and the deltoid muscle over it will be defined, 15 ml of 0.25% Bupivacaine will be placed between the deltoid muscle and subscapularis tendon using a 22 gauge-regional block needle.

Group (III)

Eligibility Criteria

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

You may qualify if:

• Adult patients.
• ASA class I and II and scheduled for elective shoulder arthroscopy.

You may not qualify if:

• Patient who refuses the regional anesthesia technique.
• History of allergy to local anesthetics.
• Local infection at the site of the block.
• History of Pre-existing major organ dysfunction such as hepatic and renal failure.
• History of pre-existing lung disease (COPD, uncontrolled asthma).
• Preexisting upper extremity neurological abnormality or neuropathy.
• Difficulties in comprehending (NRS).
• Chronic opioid users (opioid intake more than 3 months).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Shrouk Mohamed Elsawaf

Tanta, EL-Gharbia, 31527, Egypt

RECRUITING

Study Officials

• Ayman A Youssef, MD

  Professor of Anaesthesiology, Surgical Intensive Care and Pain Therapy, Faculty of Medicine, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shrouk M Elsawaf, Master

CONTACT

+201091533902; Shroukms95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: February 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: one year

Locations

EG (1)