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Clinical Efficacy of Supraclavicular Block for Arthroscopic Shoulder Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JongHae Kim, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier:
NCT01958801
First received: October 7, 2013
Last updated: April 6, 2014
Last verified: April 2014
  Purpose

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 Intervention
Horner's Syndrome
Other: Supraclavicular block
Other: Interscalene block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Comparison Between Ultrasound-guided Supraclavicular and Interscalene Brachial Plexus Blocks in the Patients Undergoing Arthroscopic Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by Daegu Catholic University Medical Center:

Primary Outcome Measures:
  • Degree of sensory blockade [ Time Frame: 20 minutes after the end of local anesthetics injection ] [ Designated as safety issue: No ]
    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:
  • Degree of motor blockade [ Time Frame: 20 minutes after the end of local anethetics injection ] [ Designated as safety issue: No ]
    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).

  • Side effects [ Time Frame: 20 minutes after the end of local anethetics injection ] [ Designated as safety issue: No ]
    Horner's syndrome (ptosis, miosis, anhidrosis) Subjective dyspnea Hoarseness

  • Frequency of intraoperative analgesics or antihypertensives use [ Time Frame: At the end of the surgery ] [ Designated as safety issue: No ]
    Frequency of intraoperative use of opioids (fentanyl) or antihypertensives (hydralazine)


Enrollment: 104
Study Start Date: September 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958801

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

Publications:
Responsible Party: JongHae Kim, Assistant Professor, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT01958801     History of Changes
Other Study ID Numbers: CR-13-033
Study First Received: October 7, 2013
Last Updated: April 6, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Daegu Catholic University Medical Center:
Supraclavicular brachial plexus block
Interscalene brachial plexus block
Arthroscopic shoulder surgery

Additional relevant MeSH terms:
Horner Syndrome
Autonomic Nervous System Diseases
Eye Diseases
Miosis
Nervous System Diseases
Neurologic Manifestations
Pupil Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014