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

Randomized Controlled Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05646667
• Other study ID #: 35915/10/22
• Status: Completed
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Interscalene Block
• Randomized Controlled Trial

Intervention

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

Locations

Country	Name	City	State
Egypt	Islam Morsy	Tanta

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