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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229696
First Posted: October 28, 2010
Last Update Posted: April 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
  Purpose
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.

Condition Intervention Phase
Popliteal Nerve Block Foot Surgery Ankle Surgery Popliteal Bifurcation Procedure: Catheter Placed At Bifurcation Procedure: Catheter Placed 5cm Above Bifurcation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia

Further study details as provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:

Primary Outcome Measures:
  • Average Pain [ Time Frame: 1 Day following surgery ]
    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).


Secondary Outcome Measures:
  • Analgesic Use [ Time Frame: 1 day following surgery ]
    Total oral opioid use since surgery and total IV analgesics if any.

  • Sleep Disturbances [ Time Frame: 1 day following surgery ]
    Total number of times patient woke due to pain the night following surgery.

  • Infusion Side Effects [ Time Frame: 1 day following surgery ]
    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 ]
    Patients will give an answer on a 0-10 scale where 0=completely unsatisfied wiht pain control and 10=completely satisfied with pain control.


Estimated Enrollment: 150
Study Start Date: October 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229696


Locations
United States, California
UCSD Medical Centers (Hillcrest and Thornton)
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

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01229696     History of Changes
Other Study ID Numbers: Popliteal Bifurcation
First Submitted: October 27, 2010
First Posted: October 28, 2010
Last Update Posted: April 11, 2016
Last Verified: April 2016

Keywords provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Popliteal
UCSD
Postoperative pain
Foot surgery
Ankle surgery
Popliteal Catheter
Popliteal Nerve Block
Lower extremity surgery
Bifurcation
Catheter Insertion Site