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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02486549
Other study ID # artroscopy
Secondary ID
Status Completed
Phase N/A
First received June 24, 2015
Last updated February 20, 2017
Start date June 2015
Est. completion date February 2017

Study information

Verified date February 2017
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the supraclavicular block to interscalene block in patients undergoing arthroscopic shoulder surgery.


Description:

The aim of this study is to evaluate the efficacy of the supraclavicular block in comparison with interscalene block on postoperative pain, quality of recovery and side effects in patients undergoing arthroscopic shoulder surgery under general anesthesia.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients undergoing shoulder surgery in American Society of Anesthesiologists physical status I-II

Exclusion Criteria:

- with a known allergy to study medications,

- chronic opioid use,

- ipsilateral upper limb neurological deficits,

- severe respiratory disease,

- coagulopathy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Supraclavicular Block
Under ultrasound guidance an insulated needle is advanced with in- plane technique into the brachial plexus sheath and 20ml 0.25% bupivacaine will be administered
Interscalene Block
Under ultrasound guidance an insulated needle will be placed through the middle scalene muscle,into the interscalene groove with in-plane technique and 20ml 0.25%bupivacaine will be administered into the brachial plexus
Drug:
Bupivacaine
20ml 0.25% bupivacaine will be injected for brachial plexus block
Device:
Ultrasound
The Ultrasound will be used for brachial plexus visualization

Locations

Country Name City State
Turkey Gaziosmanpasa University Medical School Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain The visual analog scale will be used for assessment up to postoperative 24 hours
Secondary Quality of recovery The Quality of Recovery-40 (QR40) questionnaire will be used for assessment in the postoperative 24 hours
Secondary Motor block The muscle force will be evaluated with scale 0 to 3( 0:normal muscle force, 1: reduced muscle force, 2: impaired mobility 3: paralysis up to postoperative 24 hours
Secondary Sensory block The sensorial block will be assessed by pinprick test. up to postoperative 24 hours
Secondary Adverse events The number of patients with adverse events will be recorded. up to postoperative 24 hours
Secondary Analgesics requirement time the first intravenous analgesic requirement time will be recorded. up to postoperative 24 hours
Secondary Systolic Blood pressure changes The blood pressure will be measured non invasively and the systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline will be accepted as a hypotension. at time of surgery
Secondary Heart rate changes The heart rate will be assessed via electrocardiographic monitoring and recorded as beat/minute. at time of surgery
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