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
  Purpose

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.


Condition Intervention Phase
Lower Extremity Surgery
Upper Extremity Surgery
Post-operative Pain
Procedure: Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 350
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997867

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
  More Information

No publications provided

Responsible Party: Brian Ilfeld, M.D., M.S./Principal Investigator, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00997867     History of Changes
Other Study ID Numbers: Catheter Insertion Distance
Study First Received: October 18, 2009
Last Updated: October 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Pain
Surgery
Catheter
Nerve Block
Popliteal
Sciatic
Femoral
Interscalene
UCSD
Moderate-to-severe pain
Perineural Catheter
Orthopedic Surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014