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

This study has been terminated.
(Surgeon doing procedures amenable to this study left institution.)
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01325012
First received: March 28, 2011
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Foot Surgery
Procedure: Subgluteal Sciatic Nerve Block
Procedure: Popliteal Sciatic Nerve Block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Continuous Sciatic Nerve Blocks: Popliteal Versus Subgluteal Catheters

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Muscle Strength (MVIC) of the hamstring muscles [ Time Frame: 08:00-09:00 morning after surgery as a percentage of baseline ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Sensory Effect [ Time Frame: 08:00-09:00 morning after surgery ] [ Designated as safety issue: No ]
    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.

  • Pain Scores [ Time Frame: from leaving the PACU until 08:00 the morning after surgery ] [ Designated as safety issue: No ]
    Surgical pain scores both average and worse as collected by nursing staff; and also the average and worse pain during the primary endpoint measurement

  • Sleep Disturbances [ Time Frame: recorded at 08:00-09:00 the morning after surgery for the previous night ] [ Designated as safety issue: No ]
    Total number of times patient woke in the night due to surgical pain.

  • Total Infusion [ Time Frame: recorded at 08:00-09:00 the morning following Surgery ] [ Designated as safety issue: No ]
    Total infusiond duration in time and volume and total number of boluses delivered via catheter.

  • Anesthetic Leakage [ Time Frame: recorded at 08:00-09:00 the morning following Surgery ] [ Designated as safety issue: No ]
    Leakage from the catheter site noted by patient.

  • analgesic consumption [ Time Frame: end of PACU stay until 08:00-09:00 the morning following surgery ] [ Designated as safety issue: No ]
    Hourly analgesic consumption.


Enrollment: 2
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01325012

Locations
United States, California
UCSD Medical Center, Thornton
La Jolla, California, United States
UCSD Medical Center Hillcrest
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, Department of Anesthesiology
  More Information

No publications provided

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01325012     History of Changes
Other Study ID Numbers: Subgluteal vs Popliteal
Study First Received: March 28, 2011
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
Pain
Surgery
Catheter
Nerve Block
Popliteal
Subgluteal
Sciatic
UCSD
Moderate-to-severe pain
Perineural Catheter
Orthopedic Surgery
foot surgery surgery
sciatic perineural catheter
age =>18

ClinicalTrials.gov processed this record on October 22, 2014