NCT01493986

Brief Summary

Systemic LA toxicity is an important complication of regional anesthesia. Lowering the LA dose is one of the strategies to reduce this risk. For upper limb blocks it is well documented that ultrasound guidance allows a significant lower dose of LA for interscalene and axillary blocks than with guidance by peripheral nerve stimulation. However, a corresponding difference has not yet been found for supraclavicular and infraclavicular blocks. The aim of the present study is to define the minimum effective volume of ropivacaine 7.5 mg/ml when using the LSIB method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

4 months

First QC Date

December 14, 2011

Last Update Submit

September 9, 2012

Conditions

Pain

Keywords

RopivacaineBrachial plexus

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is the minimum effective volume of ropivacaine 7.5 mg/ml providing a successful infraclavicular block (LSIB) in 50% of the patients (MEAV50).

    30 minutes

Interventions

RopivacaineDRUG

Dosage. Onset time

Also known as: Naropin

Eligibility Criteria

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

You may qualify if:

  • Patients of American Society of Anesthesiologists physical status (ASA) I-II
  • Scheduled for surgery distal to the elbow.
  • Duration of surgery \>1 hour.
  • Age 18-65 years,
  • Body mass index 20-35 kg/m2

You may not qualify if:

  • Pregnancy
  • Any contraindication to regional anesthesia
  • Patients on major opioids because of chronic pain
  • Atrioventricular block
  • Pacemaker
  • Diabetes
  • Peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Lars M Ytrebo, Professor

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 16, 2011

Study Start

February 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

NO(1)