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

NCT01229696 | Completed Phase 4

• 1 other identifier: Popliteal Bifurcation
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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).

  1 Day following surgery

Secondary Outcomes (4)

• Analgesic Use

  1 day following surgery

• Sleep Disturbances

  1 day following surgery

• Infusion Side Effects

  1 day following surgery

• Satisfaction of pain control

  1 day following surgery

Study Arms (2)

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.

Procedure: Catheter Placed At Bifurcation

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.

Procedure: Catheter Placed 5cm Above Bifurcation

Interventions

Catheter Placed At Bifurcation PROCEDURE

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.

At Bifurcation

Catheter Placed 5cm Above Bifurcation PROCEDURE

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.

5cm Above Bifurcation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Centers (Hillcrest and Thornton)

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Brian M Ilfeld, M.D., M.S.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, In Residence

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 28, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

US (1)