NCT02344615

Brief Summary

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided infraclavicular block for upper extremity surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2014

Typical duration for not_applicable pain

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

May 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

January 11, 2015

Last Update Submit

January 27, 2016

Conditions

Pain

Keywords

nerve stimulatorultrasound

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)

  • block performance time

    at 30 min after block placement

  • number of needle redirections

    at 30 min after block placement

  • patient discomfort

    at 30 min after block placement

  • paresthesia

    at 30 min after block placement

  • onset time

    until 30min after completion of local anesthetic

  • +5 more secondary outcomes

Study Arms (2)

NS-guided infraclavicular block

ACTIVE COMPARATOR

NS-guided infraclavicular block is performed using 35 ml of 0.5% ropivacaine.

Procedure: NS-guided infraclavicular block

US-guided infraclavicular block

EXPERIMENTAL

US-guided infraclavicular block is performed using 35 ml of 0.5% ropivacaine.

Procedure: US-guided infraclavicular block

Interventions

NS-guided infraclavicular blockPROCEDURE

Patients received a standard single injection infraclavicular block using the lateral sagittal approach of Klaastad. The infraclavicular brachial plexus is identified using an insulated needle connected to a nerve stimulator. Placement of the needle is considered adequate if motor response of radial nerve in the hand or wrist is still present at 0.2 - 0.5mA. Ropivacaine 0.5% 35ml is used.

NS-guided infraclavicular block
US-guided infraclavicular blockPROCEDURE

Infraclavicular block is performed under ultrasound guidance. Linear probe is placed in a parasagittal positon below the clavicle medial to the coracoid process and adjusted to achieve a cross-sectional image of the axillary artery. Using in-plane technique, an 22-gauge insulated needle is advanced caudally and posteriorly to the axillary artery. Subsequently, 35 ml of 0.5% ropivacaine is incrementally injected.

US-guided infraclavicular 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 upper extremity 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 Self-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: 25376973BACKGROUND

  • 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: 18477070BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chunwoo Yang, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and pain medicine

Study Record Dates

First Submitted

January 11, 2015

First Posted

January 26, 2015

Study Start

May 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

KR(1)