Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia

Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Erector Spinae Plane Block; Arthroscopy; Interscalene Block
• Intervention / Treatment: Procedure: Erector spinae plane block; Procedure: Interscalene brachial plexus block

Detailed Description

Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids. Among the various types of regional anesthetic techniques, the interscalene brachial plexus block (ISB) is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.

the interscalene brachial plexus block (ISB) regional anesthesia offers many advantages over general anesthesia for both arthroscopic and open surgeries of the shoulder it provides excellent intraoperative anesthesia and muscle relaxation' as well as analgesia that continues into the postoperative period

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Islam Morsy, MD; Phone Number: 139 00201093387374; Email: eslam.morsy@med.tanta.edu.eg
• Study Contact Backup: Name: Islam Morsy; Phone Number: 139 00201093387374; Email: eslam.morsy@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Islam Morsy
      • Contact: Islam Morsy; Phone Number: 139 00201093387374; Email: eslam.morsy@med.tanta.edu.eg
      • Principal Investigator: Hussein G Almawardy, MD
      • Principal Investigator: Mohammed S ElSharkawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector spinae plane block group; 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; 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
Active Comparator: Interscalene group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	Fntanyl will be administered 1 µg/kg IV increments.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable").	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	Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3.	24 hours postoperative

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: December 4, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 15, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 35914/10/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principal investigator
• IPD Sharing Time Frame: For one year after completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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