NCT02014766

Brief Summary

We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

1.1 years

First QC Date

December 6, 2013

Last Update Submit

December 12, 2013

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • pain duration

    at 24h after operation

Secondary Outcomes (7)

  • diaphragmatic movement

    preoperative, after block(at 30 min), after operation

  • motor block

    after block(at 30 min), after operation, at 24h

  • paresthesia

    after block(at 30min), after operation, at 24h

  • complications

    after block (at 30 min), after operation, at 24h

  • supplemental analgesia

    after operation, at 24h

  • +2 more secondary outcomes

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, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected.

Procedure: 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, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected.

Procedure: Supraclavicular block

Interventions

Interscalene blockPROCEDURE

Ultrasound-guided interscalene block is performed.

Interscalene block
Supraclavicular blockPROCEDURE

Ultrasound-guided supraclavicular block is performed

Supraclavicular block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists physical status I-III inpatients undergoing shoulder surgery

You may not qualify if:

  • pregnancy, severe respiratory disease, preexisting neuropathy in the operated arm, coagulopathy, allergy to study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheju Halla General Hopsital

Jeju City, Jeju Self-governing Province, 670-744, South Korea

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20565394BACKGROUND

  • 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: 20686013RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chunwoo Yang, MD

    Dep. of anesthesia and pain medicine, Cheju Halla General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunwoo Yang, MD

CONTACT

82-10-2670-0520everycw@daum.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 18, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

KR(1)