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

NCT05646667 | Completed

• 1 other identifier: 35915/10/22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Interscalene Block; Erector Spinae Plane Block; Shoulder Arthroscopy Anesthesia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Amount of 24hrs postoperative rescue analgesic consumption

  24 hours postoperatively

• Degree of pain by Numerical pain rating scale

  24 hours postoperatively

• Time to first request of rescue analgesia.

  24 hours postoperatively

Study Arms (2)

Interscalene with erector spinae plane block group

EXPERIMENTAL

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

Interscalene group

EXPERIMENTAL

Patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%.

Other: Interscalene group

Interventions

interscalene with Erector spinae plane block group OTHER

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%.

Interscalene with erector spinae plane block group

Interscalene group OTHER

patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%.

Interscalene group

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years
• Both genders,
• BMI \< 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, Egypt

Location

Study Officials

• Islam Morsy, MD

  Tanta University

  PRINCIPAL INVESTIGATOR

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 Anesthesiology, 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: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

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

Locations

EG (1)