NCT03277326

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2018

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

September 7, 2017

Last Update Submit

May 5, 2019

Conditions

Arthroscopic Shoulder SurgeryInterscalene BlockSuprascapular Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function

    To assess the pulmonary function after performance of interscalene, anterior and posterior approaches to the suprascapular block

    2 years

Secondary Outcomes (1)

  • Analgesic effects and complications

    2 years

Study Arms (3)

ISB

ACTIVE COMPARATOR

Interscalene brachial plexus block

Procedure: ISB

aSSB

ACTIVE COMPARATOR

Anterior Suprascapular Block

Procedure: aSSB

pSSB

ACTIVE COMPARATOR

Posterior Suprascapular Block

Procedure: pSSB

Interventions

ISBPROCEDURE

ISB block with 0.5% ropivicaine 15mls ( 45mg )

ISB
aSSBPROCEDURE

aSSB block with 0.5% ropivicaine 15mls ( 45mg )

aSSB
pSSBPROCEDURE

pSSB block with 0.5% ropivicaine 15mls ( 45mg )

pSSB

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Study Officials

  • Yean Chin Lim

    CGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 11, 2017

Study Start

August 30, 2017

Primary Completion

June 11, 2018

Study Completion

July 7, 2018

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)