Interscalene vs Anterior and Posterior Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries

Randomised, Controlled Trial Comparing Interscalene Versus Anterior and Posterior Approaches of Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries

To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung function and analgesia

Study Overview

• Status: Completed
• Conditions: Arthroscopic Shoulder Surgery; Interscalene Block; Suprascapular Nerve Block
• Intervention / Treatment: Procedure: ISB; Procedure: aSSB; Procedure: pSSB

Detailed Description

Interscalene block (ISB) is commonly used to provide pain control for shoulder surgeries. However, it is associated with several side effects, in particular, a high incidence of phrenic nerve blockade.

The suprascapular nerve block (SSB) has been proposed as an alternative to the ISB as it has a lower likelihood of causing phrenic nerve blockade. There are 2 commonly used approaches for the suprascapular nerve block, anterior and posterior. The anterior approach may still result in some degree of impairment of lung function.

The primary aim is to assess the pulmonary function after performance of ISB, aSSB and pSSB. Secondary outcomes are analgesic effects and incidence of adverse effects of these blocks.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for elective arthroscopic shoulder surgery under general anaesthesia
• Patients 21 years old and above
• American Society of Anesthesiologists (ASA) physical status 1 to 3
• BMI 18-35 kg/m2

Exclusion Criteria:

• Patients unable to give consent or inability to communicate/ cooperate
• Patients with chronic use of strong opioids (morphine, oxycodone)
• Patients with allergy to local anaesthetics or any drugs included in the study
• Patients with contraindications for regional anaesthesia such as coagulopathy
• Patients with pre-existing neurological deficits in upper limb/ phrenic nerve palsy
• Patients with pre-existing lung disease (COPD, uncontrolled asthma)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ISB; Interscalene brachial plexus block	Procedure: ISB; ISB block with 0.5% ropivicaine 15mls ( 45mg )
Active Comparator: aSSB; Anterior Suprascapular Block	Procedure: aSSB; aSSB block with 0.5% ropivicaine 15mls ( 45mg )
Active Comparator: pSSB; Posterior Suprascapular Block	Procedure: pSSB; pSSB block with 0.5% ropivicaine 15mls ( 45mg )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function	To assess the pulmonary function after performance of interscalene, anterior and posterior approaches to the suprascapular block	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic effects and complications	Analgesic effect (pain scores, opioid consumption, opioid related side effects), degree of motor blockade and incidence of adverse effects of blocks (Horner's syndrome, hoarseness of voice)	2 years

Collaborators and Investigators

• Sponsor: Changi General Hospital
• Investigators: Principal Investigator: Yean Chin Lim, CGH

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): June 11, 2018
• Study Completion (Actual): July 7, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 5, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017/2459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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