Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05646654
Collaborator
(none)
54
1
2
5
10.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector spinae plane block
  • Procedure: Interscalene brachial plexus block
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 (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 Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial
Anticipated Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Intraoperative fentanyl consumption [30 minutes]

    Fntanyl will be administered 1 µg/kg IV increments.

Secondary Outcome Measures

  1. Postoperative pain [24 hours postoperative]

    numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable").

  2. 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]

  3. Total amount of rescue analgesic [24 hours postoperative]

    Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Islam Morsy Tanta El-Gharbia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Islam Morsy, Lecturer of Anesthesia, Surgical Intensive Care and Pain Medicine, Tanta University
ClinicalTrials.gov Identifier:
NCT05646654
Other Study ID Numbers:
  • 35914/10/22
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:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 12, 2022