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Clinical Trials/NCT01229696
NCT01229696CompletedPhase 4

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

University of California, San Diego1 site in 1 country150 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
150
Locations
1
Primary Endpoint
Average Pain

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

At Bifurcation

Active Comparator

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: Catheter Placed At Bifurcation (Procedure)

5cm Above Bifurcation

Active Comparator

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: Catheter Placed 5cm Above Bifurcation (Procedure)

Outcomes

Primary Outcomes

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 Outcomes

  • Satisfaction of pain control(1 day following surgery)
  • Infusion Side Effects(1 day following surgery)
  • Sleep Disturbances(1 day following surgery)
  • Analgesic Use(1 day following surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brian M. Ilfeld, MD, MS

Associate Professor, In Residence

University of California, San Diego

Study Sites (1)

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