Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries

Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries

Study Overview

• Status: Completed
• Conditions: Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
• Intervention / Treatment: Procedure: interscalene block; Procedure: superior trunk block

Detailed Description

The interscalene brachial plexus block is the gold standard analgesic technique for surgery involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic paralysis, the superior trunk block was developed in an attempt to reduce major complications.The utility of the superior trunk block has yet to be studied in shoulder surgeries.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • AinShams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients American Society of Anaesthesiologists physical status (ASA) is I to II.
• Both genders.
• Aged group from 21 to 50 years old.
• Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile.

Exclusion Criteria:

• Refusal of the procedure or participation in the study.
• Any history or evidence of coagulopathy.
• Evidence of infection at injection site.
• Allergy to study drugs.
• Patients with pulmonary severe respiratory disease.
• Herniated cervical disc or cervical myelopathy.
• Pre-existing neuropathy of the operative limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: interscalene block group; participants undergoing shoulder surgeries will receive ultrasound guided interscalene block	Procedure: interscalene block; will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.; Procedure: superior trunk block; will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.
Active Comparator: superior trunk block group; participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block	Procedure: interscalene block; will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.; Procedure: superior trunk block; will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diaphragmatic paralysis postoperative	o The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound	within 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesic efficacy	o Analgesic efficacy of the nerve block in both groups by assessing postoperative pain vas score	within 24 hours after surgery
rescue analgesia	The total amount of rescue analgesia used	within 24 hours after surgery
Post operative nausea and vomiting	incidence of post operative complications as nausea an vomiting	within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: interscalene block; superior trunk block
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: superior trunk vs interscalene

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No