Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia

NCT05646654 | Unknown

• 1 other identifier: 35914/10/22
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effectiveness of ESPB versus ISB in anesthesia for shoulder arthroscopy

Conditions

Interscalene Block; Erector Spinae Plane Block; Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Intraoperative fentanyl consumption

  Fntanyl will be administered 1 µg/kg IV increments.

  30 minutes

Secondary Outcomes (3)

• Postoperative pain

  24 hours postoperative

• Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3. Time to the 1st rescue analgesic request will be recorded

  24 hours postoperative

• Total amount of rescue analgesic

  24 hours postoperative

Study Arms (2)

Erector spinae plane block group

ACTIVE COMPARATOR

3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 20 ml bupivacaine 0.5% will be injected.

Procedure: Erector spinae plane block

Interscalene group

ACTIVE COMPARATOR

Using a lateral-to-medial approach, the 25-gauge needle will be inserted into the middle scalene muscle, advanced, and placed immediately lateral to the nerve roots. the needle will be visualize using an ultrasound beam to avoid intraneural and intravascular injections. After confirming negative blood aspiration, we will inject 15 mL of 0.5% bupivacaine around the nerve roots

Procedure: Interscalene brachial plexus block

Interventions

Erector spinae plane block PROCEDURE

Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 20 ml bupivacaine 0.5% will be injected

Erector spinae plane block group

Interscalene brachial plexus block PROCEDURE

Using a lateral-to-medial approach, the 25-gauge needle will be inserted into the middle scalene muscle, advanced, and placed immediately lateral to the nerve roots. the needle will be visualize using an ultrasound beam to avoid intraneural and intravascular injections. After confirming negative blood aspiration, we will inject 15 mL of 0.5% bupivacaine around the nerve roots

Interscalene group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Body Mass Index \< 40 kg/m2
• American Society of Anesthesiologists (ASA) physical status I-II
• scheduled for elective shoulder arthroscopy

You may not qualify if:

• Known allergy to local anesthetics
• Allergy to all opioid medications
• Diagnostic shoulder arthroscopic procedures
• Patients with chronic opioids
• Patients who converted to general anesthesia use and coagulopathy

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Islam Morsy

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Islam Morsy, MD

CONTACT

00201093387374; eslam.morsy@med.tanta.edu.eg

Islam Morsy

CONTACT

00201093387374; eslam.morsy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 12, 2022
• Study Start: December 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: For one year after completion of the study

Locations

EG (1)