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Clinical Efficacy of Supraclavicular Block for Arthroscopic Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT01958801
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
JongHae Kim, Daegu Catholic University Medical Center

Study Description
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Brief Summary:
The aim of this study is to compare the efficacy of supraclavicular and interscalene brachial plexus blocks in the patients undergoing arthroscopic shoulder surgery.

Condition or disease Intervention/treatment Phase
Horner's Syndrome Other: Supraclavicular block Other: Interscalene block Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Comparison Between Ultrasound-guided Supraclavicular and Interscalene Brachial Plexus Blocks in the Patients Undergoing Arthroscopic Shoulder Surgery
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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Arms and Interventions
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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.
 Other: Interscalene block
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.
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.
 Other: Supraclavicular block
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.


Outcome Measures
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Primary Outcome Measures :
  1. Degree of sensory blockade [ Time Frame: 20 minutes after the end of local anesthetics injection ]
    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.


Secondary Outcome Measures :
  1. Degree of motor blockade [ Time Frame: 20 minutes after the end of local anethetics injection ]
    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).

  2. Side effects [ Time Frame: 20 minutes after the end of local anethetics injection ]
    Horner's syndrome (ptosis, miosis, anhidrosis) Subjective dyspnea Hoarseness

  3. Frequency of intraoperative analgesics or antihypertensives use [ Time Frame: At the end of the surgery ]
    Frequency of intraoperative use of opioids (fentanyl) or antihypertensives (hydralazine)


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958801


Locations
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Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of, 705-718
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
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Principal Investigator: JongHae Kim, Master Daegu Catholic University Medical Center
More Information
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Publications:

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Responsible Party: JongHae Kim, Assistant Professor, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT01958801    
Other Study ID Numbers: CR-13-033
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014
Keywords provided by JongHae Kim, Daegu Catholic University Medical Center:
Supraclavicular brachial plexus block
Interscalene brachial plexus block
Arthroscopic shoulder surgery
Additional relevant MeSH terms:
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Horner Syndrome
Autonomic Nervous System Diseases
Nervous System Diseases
Miosis
 Pupil Disorders
Neurologic Manifestations
Eye Diseases