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 October 2014 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: October 28, 2014
Last verified: October 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01229696

Contacts
Contact: Brian M Ilfeld, M.D., M.S. 619-543-5742 bilfeld@ucsd.edu

Locations
United States, California
UCSD Medical Centers (Hillcrest and Thornton) Recruiting
San Diego, California, United States, 92103
Contact: Brian M Ilfeld, M.D., M.S.    619-543-5742    bilfeld@ucsd.edu   
Principal Investigator: Brian M Ilfeld, M.D., M.S.         
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 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
Study First Received: October 27, 2010
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on October 30, 2014