- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01958801
Clinical Efficacy of Supraclavicular Block for Arthroscopic Shoulder Surgery
April 6, 2014 updated by: JongHae Kim, Daegu Catholic University Medical Center
Comparison Between Ultrasound-guided Supraclavicular and Interscalene Brachial Plexus Blocks in the Patients Undergoing Arthroscopic Shoulder Surgery
The aim of this study is to compare the efficacy of supraclavicular and interscalene brachial plexus blocks in the patients undergoing arthroscopic shoulder surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to compare supraclavicular brachial plexus block to interscalene brachial plexus block with regard to degree of sensory and motor blockades, side effects and complications of the blocks, and frequency of intraoperative analgesics or antihypertensives use.
Study Type
Interventional
Enrollment (Actual)
104
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 Locations
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Daegu, Korea, Republic of, 705-718
- Daegu Catholic University Medical Center
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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
15 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologists physical status I-II
- Body mass index < 35 kg/m2
Exclusion Criteria:
- Neurologic deficits on the side to be blocked
- Infection or inflammation at the puncture site for brachial plexus block
- Psychiatric disorders
- Patient refusal
- Difficulty to communicate
- Coagulation deficiencies
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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, nerve stimulation needle is advanced into the brachial plexus sheath, into which 25 ml of 1.5% mepivacaine is injected.
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Redirection of the needle is allowed when spread of local anesthetics does not surround the brachial plexus appropriately and involuntary movement of the forearm or hand is not necessary to confirm the correct placement of the needle.
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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, nerve stimulation needle is advanced into the brachial plexus sheath, into which 25 ml of 1.5% mepivacaine is injected.
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Redirection of the needle is allowed when spread of local anesthetics does not surround the brachial plexus appropriately and involuntary movement of the forearm or hand is not necessary to confirm the correct placement of the needle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of sensory blockade
Time Frame: 20 minutes after the end of local anesthetics injection
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Sensory blockade of the C5 to T1 dermatomes was assessed by rating the absence of cold sensation between 100 (intact sensation) and 0 (no sensation) with an alcohol swab.
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20 minutes after the end of local anesthetics injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of motor blockade
Time Frame: 20 minutes after the end of local anethetics injection
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Motor blockade was evaluated by elbow and wrist extension (radial nerve), finger abduction (ulnar nerve), wrist flexion (median nerve), and elbow flexion (musculocutaneous nerve).
The muscle force was rated on a scale of 0 to 6 as follows (6: normal muscle force; 5: slightly reduced muscle force; 4: greatly reduced muscle force; 3: slightly impaired mobility; 2: greatly impaired mobility; 1: near complete paralysis; 0: complete paralysis).
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20 minutes after the end of local anethetics injection
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Side effects
Time Frame: 20 minutes after the end of local anethetics injection
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Horner's syndrome (ptosis, miosis, anhidrosis) Subjective dyspnea Hoarseness
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20 minutes after the end of local anethetics injection
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Frequency of intraoperative analgesics or antihypertensives use
Time Frame: At the end of the surgery
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Frequency of intraoperative use of opioids (fentanyl) or antihypertensives (hydralazine)
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At the end of the surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: JongHae Kim, Master, Daegu Catholic University Medical Center
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
- 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.
- Conroy PH, Awad IT. Ultrasound-guided blocks for shoulder surgery. Curr Opin Anaesthesiol. 2011 Dec;24(6):638-43. doi: 10.1097/ACO.0b013e32834c155f.
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
September 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
October 7, 2013
First Submitted That Met QC Criteria
October 7, 2013
First Posted (Estimate)
October 9, 2013
Study Record Updates
Last Update Posted (Estimate)
April 8, 2014
Last Update Submitted That Met QC Criteria
April 6, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-13-033
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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