Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01229696
First received: October 27, 2010
Last updated: November 4, 2013
Last verified: November 2013

October 27, 2010
November 4, 2013
October 2010
December 2014   (final data collection date for primary outcome measure)
Average Pain [ Time Frame: 1 Day following surgery ] [ Designated as safety issue: No ]
The 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).
Same as current
Complete list of historical versions of study NCT01229696 on ClinicalTrials.gov Archive Site
  • Analgesic Use [ Time Frame: 1 day following surgery ] [ Designated as safety issue: No ]
    Total oral opioid use since surgery and total IV analgesics if any.
  • Sleep Disturbances [ Time Frame: 1 day following surgery ] [ Designated as safety issue: No ]
    Total number of times patient woke due to pain the night following surgery.
  • Infusion Side Effects [ Time Frame: 1 day following surgery ] [ Designated as safety issue: No ]
    Numbness of foot and toes on a 0-10 scale where 0=no numbness and 10=complete numbness.
  • Satisfaction of pain control [ Time Frame: 1 day following surgery ] [ Designated as safety issue: No ]
    Patients will give an answer on a 0-10 scale where 0=completely unsatisfied wiht pain control and 10=completely satisfied with pain control.
Same as current
Not Provided
Not Provided
 
Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia
Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia

Research study to determine the relationship between perineural catheter tip location relative to the sciatic nerve bifurcation and postoperative analgesia for continuous popliteal nerve blocks.

Hypothesis: During a continuous popliteal nerve block, postoperative analgesia will be improved with the perineural catheter tip at the level of the sciatic nerve bifurcation compared to when the catheter tip is 5 cm cephalad/proximal to the bifurcation.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Popliteal Nerve Block
  • Foot Surgery
  • Ankle Surgery
  • Popliteal Bifurcation
  • Procedure: Catheter Placed At Bifurcation
    Patients randomized to this group will receive a sciatic nerve block placed at the bifurcaton of the sciatic nerve and outcome measures will be tested.
  • Procedure: Catheter Placed 5cm Above Bifurcation
    Patients randomized to this group will receive a sciatic nerve block placed 5cm above the bifurcaton of the sciatic nerve and outcome measures will be tested.
  • Active Comparator: At Bifurcation
    Patients randomized to this group will receive a sciatic nerve block placed at the bifurcaton of the sciatic nerve and outcome measures will be tested.
    Intervention: Procedure: Catheter Placed At Bifurcation
  • Active Comparator: 5cm Above Bifurcation
    Patients randomized to this group will receive a sciatic nerve block placed 5cm above the bifurcaton of the sciatic nerve and outcome measures will be tested.
    Intervention: Procedure: Catheter Placed 5cm Above Bifurcation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • undergoing surgery with a 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
  • a history of opioid abuse
  • surgery outside of ipsilateral sciatic and saphenous nerve distributions
Both
18 Years and older
No
Contact: Brian M Ilfeld, M.D., M.S. 619-543-5742 bilfeld@ucsd.edu
United States
 
NCT01229696
Popliteal Bifurcation
No
Brian M. Ilfeld, MD, MS, University of California, San Diego
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
November 2013

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