NCT02342873

Brief Summary

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided interscalene block after shoulder surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

December 11, 2014

Last Update Submit

July 13, 2017

Conditions

Pain

Keywords

ultrasoundnerve stimulator

Outcome Measures

Primary Outcomes (1)

  • duration of postoperative analgesia

    time from completion of local anesthetic injection until the first request for an analgesic

    at 24h after surgery

Secondary Outcomes (10)

  • onset time (complete block of sensory and motor nerve)

    until 30min after completion of local anesthetic

  • patient discomfort (pain score (0 -10) during the procedure)

    at 30 min after block placement

  • block performance time (the time between the block needle insertion and needle withdrawal)

    at 30 min after block placement

  • The number of needle redirections

    at 30 min after block placement

  • paresthesia (presence of paresthesia during the procedure)

    at 30 min after block placement

  • +5 more secondary outcomes

Study Arms (2)

NS-guided interscalene block

ACTIVE COMPARATOR

NS-guided interscalene block is performed using 20 ml of 0.75% ropivacaine.

Procedure: NS-guided interscalene block

US-guided interscalene block

EXPERIMENTAL

US-guided interscalene block is performed using 20 ml of 0.75% ropivacaine.

Procedure: US-guided interscalene block

Interventions

NS-guided interscalene blockPROCEDURE

Patients received a standard single injection interscalene block using the modified lateral approach of Borgeat. The interscalene brachial plexus was identified using an insulated needle connected to a nerve stimulator. An insulated needle attached to a nerve stimulator was used to identify the brachial plexus. Placement of the needle was considered adequate if the deltoid, triceps, pectoralis, or biceps muscle motor response was still present at 0.2 - 0.5mA. Ropivacine 0.75% 20ml was used.

NS-guided interscalene block
US-guided interscalene blockPROCEDURE

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 0.75% ropivacaine is injected

US-guided interscalene 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 class I - III patients scheduled to undergo shoulder surgery

You may not qualify if:

  • coagulopathy, severe pulmonary disease, neuropathy, contralateral diaphragmatic paresis, allergy to study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheju Halla General Hopsital

Jeju City, Jeju Special Governing Province, 670-744, South Korea

Location

Related Publications (2)

  • Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.

    PMID: 25376973RESULT

  • Koscielniak-Nielsen ZJ. Ultrasound-guided peripheral nerve blocks: what are the benefits? Acta Anaesthesiol Scand. 2008 Jul;52(6):727-37. doi: 10.1111/j.1399-6576.2008.01666.x. Epub 2008 May 12.

    PMID: 18477070RESULT

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

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
PRINCIPAL INVESTIGATOR
PI Title
staff anesthesiologist

Study Record Dates

First Submitted

December 11, 2014

First Posted

January 21, 2015

Study Start

March 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Locations

KR(1)