Ultrasound-Guided Continuous Sciatic Nerve Blocks: Popliteal Versus Subgluteal Catheters

March 27, 2013 updated by: Brian M. Ilfeld, MD, MS, University of California, San Diego
To determine the relationship between perineural catheter location along the sciatic nerve (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided continuous sciatic nerve blocks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States
        • UCSD Medical Center, Thornton
      • San Diego, California, United States, 92103
        • UCSD Medical Center Hillcrest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergoing foot surgery with a sciatic perineural catheter for postoperative analgesia
  • spending the first postoperative night hospitalized
  • age 18 years or older

Exclusion Criteria:

  • pregnancy
  • inability to communicate with the investigators and hospital staff
  • incarceration
  • clinical neuropathy in the surgical extremity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subgluteal Sciatic Nerve Block
Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle.
Procedure: Subgluteal Sciatic Nerve Block
Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle. After catheter placement, outcome measures will be assessed.
Active Comparator: Popliteal Sciatic Nerve Block
Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation.
Procedure: Popliteal Sciatic Nerve Block
Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After Catheter placement outcome measures will be assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Strength (MVIC) of the hamstring muscles
Time Frame: 08:00-09:00 morning after surgery as a percentage of baseline
We will evaluate hamstring strength which is innervated by the sciatic nerve with an isometric force electromechanical dynamometer to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90º
08:00-09:00 morning after surgery as a percentage of baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory Effect
Time Frame: 08:00-09:00 morning after surgery
We will evaluate tolerance of transcutaneous electrical stimulation. Electrocardiogram pads will be placed on the plantar and dorsal aspects of the foot, and attached to a nerve stimulator. The current will be increased from 0 mA until subjects described a "buzzing" sensation (not painful), at which time the current will be recorded as the tolerated level and the nerve stimulator turned off.
08:00-09:00 morning after surgery
Pain Scores
Time Frame: from leaving the PACU until 08:00 the morning after surgery
Surgical pain scores both average and worse as collected by nursing staff; and also the average and worse pain during the primary endpoint measurement
from leaving the PACU until 08:00 the morning after surgery
Sleep Disturbances
Time Frame: recorded at 08:00-09:00 the morning after surgery for the previous night
Total number of times patient woke in the night due to surgical pain.
recorded at 08:00-09:00 the morning after surgery for the previous night
Total Infusion
Time Frame: recorded at 08:00-09:00 the morning following Surgery
Total infusiond duration in time and volume and total number of boluses delivered via catheter.
recorded at 08:00-09:00 the morning following Surgery
Anesthetic Leakage
Time Frame: recorded at 08:00-09:00 the morning following Surgery
Leakage from the catheter site noted by patient.
recorded at 08:00-09:00 the morning following Surgery
analgesic consumption
Time Frame: end of PACU stay until 08:00-09:00 the morning following surgery
Hourly analgesic consumption.
end of PACU stay until 08:00-09:00 the morning following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Brian M Ilfeld, M.D., M.S., University of California, Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Subgluteal vs Popliteal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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