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

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05646667

Collaborator

(none)

Enrollment

Location

Arms

9.2

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Interscalene Block Erector Spinae Plane Block Shoulder Arthroscopy Anesthesia Randomized Controlled Trial	Other: interscalene with Erector spinae plane block group Other: Interscalene group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Sep 20, 2023

Anticipated Study Completion Date :

Sep 20, 2023

Arms and Interventions

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%.

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%.

Outcome Measures

Primary Outcome Measures

Intraoperative fentanyl consumption [Intraoperative up to 4 hours]
If the patient complains of pain during surgery, fentanyl will be administered 1 µg/kg IV increments.

Secondary Outcome Measures

Amount of 24hrs postoperative rescue analgesic consumption [24 hours postoperatively]
Intravenous meperidine (0.5 mg/kg) will be administered if numerical pain rating scale (NRS) score of more than 3.
Degree of pain by Numerical pain rating scale [24 hours postoperatively]
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").
Time to first request of rescue analgesia. [24 hours postoperatively]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Islam Morsy	Tanta		Egypt

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: Islam Morsy, MD, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Islam Morsy, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University

ClinicalTrials.gov Identifier:

NCT05646667

Other Study ID Numbers:

35915/10/22

First Posted:

Dec 12, 2022

Last Update Posted:

Dec 12, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 12, 2022