NCT01958801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

October 7, 2013

Last Update Submit

April 6, 2014

Conditions

Horner's Syndrome

Keywords

Supraclavicular brachial plexus blockInterscalene brachial plexus blockArthroscopic shoulder surgery

Outcome Measures

Primary Outcomes (1)

  • Degree of sensory blockade

    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.

    20 minutes after the end of local anesthetics injection

Secondary Outcomes (3)

  • Degree of motor blockade

    20 minutes after the end of local anethetics injection

  • Side effects

    20 minutes after the end of local anethetics injection

  • Frequency of intraoperative analgesics or antihypertensives use

    At the end of the surgery

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

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

Supraclavicular block

EXPERIMENTAL

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

Interventions

Supraclavicular blockOTHER

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.

Supraclavicular block
Interscalene blockOTHER

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.

Interscalene block

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists physical status I-II
  • Body mass index \< 35 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 705-718, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 20686013BACKGROUND

  • Conroy PH, Awad IT. Ultrasound-guided blocks for shoulder surgery. Curr Opin Anaesthesiol. 2011 Dec;24(6):638-43. doi: 10.1097/ACO.0b013e32834c155f.

    PMID: 21934495BACKGROUND

MeSH Terms

Conditions

Horner Syndrome

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesCavernous Sinus SyndromesBrain DiseasesCentral Nervous System DiseasesMiosisPupil DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • JongHae Kim, Master

    Daegu Catholic University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

KR(1)