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CompletedNCT01229696Updated Apr 11, 2016

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

A Phase 4 interventional study of Catheter Placed At Bifurcation and Catheter Placed 5cm Above Bifurcation in Popliteal Nerve Block, Foot Surgery and Ankle Surgery, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-11.

Sponsored by University of California, San Diego · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Popliteal Nerve Block
  • Foot Surgery
  • Ankle Surgery
  • Popliteal Bifurcation

Keywords

  • Popliteal
  • UCSD
  • Postoperative pain
  • Foot surgery
  • Ankle surgery
  • Popliteal Catheter
  • Popliteal Nerve Block
  • Lower extremity surgery
  • Bifurcation
  • Catheter Insertion Site
03

In context

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureCatheter 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.

  • ProcedureCatheter 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.

06

What researchers measure

Primary outcomes

  1. Average Pain

    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).

    Time frame: 1 Day following surgery

Secondary outcomes

  1. Analgesic Use

    Total oral opioid use since surgery and total IV analgesics if any.

    Time frame: 1 day following surgery

  2. Sleep Disturbances

    Total number of times patient woke due to pain the night following surgery.

    Time frame: 1 day following surgery

  3. Infusion Side Effects

    Numbness of foot and toes on a 0-10 scale where 0=no numbness and 10=complete numbness.

    Time frame: 1 day following surgery

  4. Satisfaction of pain control

    Patients will give an answer on a 0-10 scale where 0=completely unsatisfied wiht pain control and 10=completely satisfied with pain control.

    Time frame: 1 day following surgery

07

Study locations

1 site
  • UCSD Medical Centers (Hillcrest and Thornton)
    San Diego, California 92103, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01229696
Lead sponsor
University of California, San Diego
Responsible party
Brian M. Ilfeld, MD, MS (Associate Professor, In Residence, University of California, San Diego) — Principal investigator
First posted
Oct 28, 2010
Start date
Oct 2010
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Apr 11, 2016

Study contacts

Brian M Ilfeld, M.D., M.S.
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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