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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05646654
Other study ID # 35914/10/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2022
Est. completion date May 15, 2023

Study information

Verified date April 2023
Source Tanta University
Contact Islam Morsy, MD
Phone 00201093387374
Email eslam.morsy@med.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date May 15, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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
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

Locations

Country Name City State
Egypt Islam Morsy Tanta El-Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative fentanyl consumption Fntanyl will be administered 1 µg/kg IV increments. 30 minutes
Secondary Postoperative pain numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable"). 24 hours postoperative
Secondary 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
Secondary Total amount of rescue analgesic Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3. 24 hours postoperative
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