NCT00523055

Brief Summary

Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing performed. The quality of physiotherapy is felt to be superior with good pain control. The quality of the freezing is felt to be better when it is done with ultrasound guidance. We are able to use less drug to achieve the same result. For this reason, we are doing a study to look at the level of freezing drug that accumulates in the body. We feel that the drug levels will be significantly different. We also feel that the time-to-peak drug level will be different than with traditional arm freezing procedures.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Last Updated

May 10, 2017

Status Verified

April 1, 2011

Enrollment Period

3.9 years

First QC Date

August 28, 2007

Last Update Submit

May 9, 2017

Conditions

Keywords

PainBrachial Plexus AnesthesiaPlasma Lidocaine LevelsUltrasound

Outcome Measures

Primary Outcomes (1)

  • Lidocaine drug level

    40 minutes

Secondary Outcomes (2)

  • brachial plexus block quality

    30 minutes

  • Physiotherapy quality

    within 2 hours

Interventions

Lidocaine, 5 mg/kg, via needle placed adjacent to brachial plexus with ultrasound, dosing separated by 1 week, 2 doses in total, one block will contain 5 mcg/kg of adrenaline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing brachial plexus anesthesia as part of disease management who have consented to participate in the study

You may not qualify if:

  • Contraindication to brachial plexus anesthesia
  • Informed consent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Pain Management Centre

Winnipeg, Manitoba, R3P1S4, Canada

Location

Related Publications (4)

  • Neal JM, Hebl JR, Gerancher JC, Hogan QH. Brachial plexus anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):402-28. doi: 10.1053/rapm.2002.34377. No abstract available.

    PMID: 12132064BACKGROUND
  • Norder H, Hammas B, Larsen J, Skaug K, Magnius LO. Detection of HBV DNA by PCR in serum from an HBsAg negative blood donor implicated in cases of post-transfusion hepatitis B. Arch Virol Suppl. 1992;4:116-8. doi: 10.1007/978-3-7091-5633-9_24.

    PMID: 1450678BACKGROUND
  • Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.

    PMID: 17196502BACKGROUND
  • Beach ML, Sites BD, Gallagher JD. Use of a nerve stimulator does not improve the efficacy of ultrasound-guided supraclavicular nerve blocks. J Clin Anesth. 2006 Dec;18(8):580-4. doi: 10.1016/j.jclinane.2006.03.017.

    PMID: 17175426BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Eric N Sutherland, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

May 1, 2008

Primary Completion

April 1, 2012

Last Updated

May 10, 2017

Record last verified: 2011-04

Locations