Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00997867
First received: October 18, 2009
Last updated: October 27, 2010
Last verified: October 2010

October 18, 2009
October 27, 2010
November 2009
October 2010   (final data collection date for primary outcome measure)
Average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain). [ Time Frame: Day 1 after surgery, 3 hours prior to phone call ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00997867 on ClinicalTrials.gov Archive Site
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Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks
Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

This is a research study to determine if the effects of continuous peripheral nerve blocks are influenced by the distance of insertion past the needle tip of the perineural catheter.

Specific Aim: Research study to determine the relationships between perineural catheter insertion distance and subsequent continuous peripheral nerve block effects.

Hypothesis: during ultrasound-guided perineural catheter placement, inserting the catheter 0-1cm past the needle tip is associated with decreased postoperative pain compared with inserting the catheter 5-6cm past the needle tip.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Lower Extremity Surgery
  • Upper Extremity Surgery
  • Post-operative Pain
Procedure: Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip
Patients undergoing orthopedic surgery who are getting a perineural catheter will be randomized to one of two groups: catheter tip placed 0-1cm past needle tip or catheter tip placed 5-6cm past needle tip. Patients will be called by research staff the day following surgery to assess their post-surgical pain using a numeric rating scale.
  • Active Comparator: Catheter 0-1cm past needle tip
    Patients will be receiving a sciatic (popliteal), femoral, or interscalene nerve block and will be randomized to having the catheter placed 0-1cm past the needle tip. The patient will be called the following day by research staff to assess their post-surgical pain.
    Intervention: Procedure: Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip
  • Active Comparator: Catheter placed 5-6cm past needle tip
    Patients will be receiving a sciatic (popliteal), femoral, or interscalene nerve block and will be randomized to having the catheter placed 5-6cm past the needle tip. Patients will be called the following day by research staff to assess their post-surgical pain.
    Intervention: Procedure: Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • undergoing surgery with a planned popliteal perineural catheter for postoperative analgesia
  • age 18 years or older

Exclusion Criteria:

  • pregnancy
  • inability to communicate with the investigators and hospital staff
  • incarceration
  • clinical neuropathy in the surgical extremity
  • chronic high-dose opioid use
  • history of opioid abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00997867
Catheter Insertion Distance
No
Brian Ilfeld, M.D., M.S./Principal Investigator, University of California, San Diego, Department of Anesthesiology
University of California, San Diego
Not Provided
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
University of California, San Diego
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP