- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014766
Supraclavicular Versus Interscalene Block
December 12, 2013 updated by: Cheju Halla General Hospital
A Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block After Shoulder Surgery
We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Interscalene block provides effective postoperative analgesia after shoulder surgery.
However, it can be associated with significant risk including the phrenic nerve palsy.
Previous study reported that ultrasound-guided interscalene and supraclavicular blocks are effective and safe for shoulder arthroscopy.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chunwoo Yang, MD
- Phone Number: 82-10-2670-0520
- Email: everycw@daum.net
Study Locations
-
-
Jeju self-governing province
-
Jeju, Jeju self-governing province, Korea, Republic of, 670-744
- Recruiting
- Cheju Halla General Hopsital
-
Contact:
- Chunwoo Yang, MD
- Phone Number: 82-10-2670-0520
- Email: everycw@daum.net
-
Principal Investigator:
- Chunwoo Yang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
American Society of Anesthesiologists physical status I-III inpatients undergoing shoulder surgery
Exclusion Criteria:
pregnancy, severe respiratory disease, preexisting neuropathy in the operated arm, coagulopathy, allergy to study medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Interscalene block
Interscalene block is performed under ultrasound guidance.
Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles.
Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected.
|
Ultrasound-guided interscalene block is performed.
|
Experimental: Supraclavicular block
Supraclavicular block is performed under ultrasound guidance.
Linear probe is placed on the ipsilateral supraclavicular fossa visualizing the brachial plexus located lateral to the subclavian artery.
Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected.
|
Ultrasound-guided supraclavicular block is performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain duration
Time Frame: at 24h after operation
|
at 24h after operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
diaphragmatic movement
Time Frame: preoperative, after block(at 30 min), after operation
|
preoperative, after block(at 30 min), after operation
|
motor block
Time Frame: after block(at 30 min), after operation, at 24h
|
after block(at 30 min), after operation, at 24h
|
paresthesia
Time Frame: after block(at 30min), after operation, at 24h
|
after block(at 30min), after operation, at 24h
|
complications
Time Frame: after block (at 30 min), after operation, at 24h
|
after block (at 30 min), after operation, at 24h
|
supplemental analgesia
Time Frame: after operation, at 24h
|
after operation, at 24h
|
pain score
Time Frame: at 24h
|
at 24h
|
patient satisfaction
Time Frame: at 24h
|
at 24h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chunwoo Yang, MD, Dep. of anesthesia and pain medicine, Cheju Halla General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
- Liu SS, Gordon MA, Shaw PM, Wilfred S, Shetty T, Yadeau JT. A prospective clinical registry of ultrasound-guided regional anesthesia for ambulatory shoulder surgery. Anesth Analg. 2010 Sep;111(3):617-23. doi: 10.1213/ANE.0b013e3181ea5f5d. Epub 2010 Aug 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
December 6, 2013
First Submitted That Met QC Criteria
December 12, 2013
First Posted (Estimate)
December 18, 2013
Study Record Updates
Last Update Posted (Estimate)
December 18, 2013
Last Update Submitted That Met QC Criteria
December 12, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Inter1
- 2013-M10 (Other Identifier: Cheju Halla General Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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