Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia

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

The aim of this study is to compare the effectiveness of interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block in anesthesia for shoulder arthroscopy.

Study Overview

• Status: Completed
• Conditions: Erector Spinae Plane Block; Randomized Controlled Trial; Interscalene Block; Shoulder Arthroscopy Anesthesia
• Intervention / Treatment: Other: interscalene with Erector spinae plane block group; Other: Interscalene group

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 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Egypt
  • Tanta, Egypt
    • Islam Morsy
    • Sub-Investigator: Mohammed Said El Sharkawy, Assistant Lecturer
    • Contact: Islam Morsy; Phone Number: 139 00201093387374; Email: eslam.morsy@med.tanta.edu.eg
    • Sub-Investigator: Islam Morsy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18-65 years
• Both genders,
• BMI < 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
Experimental: Interscalene with erector spinae plane block group; Patients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and ultrasound guided erector spinae plane block at thoracic (T2) using 10 ml of bupivacaine 0.5%.	Other: interscalene with Erector spinae plane block group; patients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and US guided Erector spinae plane block at T2 using 10 ml of bupivacaine 0.5%.
Experimental: Interscalene group; Patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%.	Other: Interscalene group; patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	If the patient complains of pain during surgery, fentanyl will be administered 1 µg/kg IV increments.	Intraoperative up to 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of 24hrs postoperative rescue analgesic consumption	Intravenous meperidine (0.5 mg/kg) will be administered if numerical pain rating scale (NRS) score of more than 3.	24 hours postoperatively
Degree of pain by Numerical pain rating scale	Postoperative pain (using NRS at admission) will be measured at PACU, 1h, 2hr. 4hr, 6hr, 8hr, 12hr, 18hr, and 24hrs postoperative. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").	24 hours postoperatively
Time to first request of rescue analgesia.	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 postoperatively

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Islam Morsy, MD, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 35915/10/22

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 principle investigator.
• IPD Sharing Time Frame: from 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