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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03277326
Other study ID # 2017/2459
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2017
Est. completion date July 7, 2018

Study information

Verified date May 2019
Source Changi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 7, 2018
Est. primary completion date June 11, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Intervention

Procedure:
ISB
ISB block with 0.5% ropivicaine 15mls ( 45mg )
aSSB
aSSB block with 0.5% ropivicaine 15mls ( 45mg )
pSSB
pSSB block with 0.5% ropivicaine 15mls ( 45mg )

Locations

Country Name City State
Singapore Changi General Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary function To assess the pulmonary function after performance of interscalene, anterior and posterior approaches to the suprascapular block 2 years
Secondary 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
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