Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00876681
First received: April 3, 2009
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

Research study to determine if pain relief following foot and/or ankle surgery is influenced by the technique used to place perineural catheter. The catheters are placed using ultrasound-guidance or nerve stimulation and the method is selected at random using a computer program. This may help to determine if one of these methods is associated with an increased success rate and incidence of foot numbness during the infusion.


Condition Intervention Phase
Postoperative Pain
Foot Numbness
Procedure: Popliteal catheter placed via ultrasound or electrical stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks: A Randomized, Controlled Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary outcome measurement will be the average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (NRS, 0-10, 0=no pain, 10=worst imaginable pain). [ Time Frame: 3 hours on day following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensory deficit in the operative limb the day following surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at time of the data collection phone call. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Time for catheter placement. Time will begin when probe is placed on skin for the ultrasound-guidance method and when the nerve stimulation needle is placed on the skin for the electrical stimulation method. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Catheter placement success rate as assessed by attending physician who will test for sensory deficit. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Worst pain experienced since the surgery in the surgical limb as measured on the 0-10 NRS as assessed by the research staff when they call the patient the day following surgery. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Ultrasound
Ultrasound method of placement is selected randomly, using a computer program. The patient is asked their pain and discomfort using a 0-10 scale where 0=no pain/discomfort and 10=worst pain/discomfort imaginable. The patient is asked this question prior to surgery, but after catheter placement and then again the first day after surgery. Time of placement is also measured and begins when the ultrasound probe first touches the skin. Patients are also asked the numbness of their foot and toes based on a 0-10 scale where 0=no numbness and 10=completely numb.
Procedure: Popliteal catheter placed via ultrasound or electrical stimulation
Patients will be randomized to one of two groups: Popliteal-sciatic catheter placed via ultrasound-guidance or placed via electrical stimulation. All patients will be given 40ml of 1.5% mepivicaine prior to surgery and then given a pain pump after surgery containing 0.2% ropivacaine. The patients pain scores will be assessed just prior to surgery and the day following surgery. The time of catheter placement and numbness the patient is experiencing in their foot and toes is also assessed and recorded by research staff.
Active Comparator: 2. Electrical Stimulation
Electrical stimulation (nerve stimulation) method of placement is selected randomly, using a computer program. The patient is asked their pain and discomfort using a 0-10 scale where 0=no pain/discomfort and 10=worst pain/discomfort imaginable. The patient is asked this question prior to surgery, but after catheter placement, and then again the first day after surgery. Time of placement is also measured and begins when the nerve stimulation needle first touches the skin. Patients are also asked the numbness of their foot and toes based on a 0-10 scale where 0=no numbness and 10=completely numb.
Procedure: Popliteal catheter placed via ultrasound or electrical stimulation
Patients will be randomized to one of two groups: Popliteal-sciatic catheter placed via ultrasound-guidance or placed via electrical stimulation. All patients will be given 40ml of 1.5% mepivicaine prior to surgery and then given a pain pump after surgery containing 0.2% ropivacaine. The patients pain scores will be assessed just prior to surgery and the day following surgery. The time of catheter placement and numbness the patient is experiencing in their foot and toes is also assessed and recorded by research staff.

Detailed Description:

Specific Aim 1: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and quality of postoperative analgesia during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.

Hypothesis 1: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with decreased pain the morning following moderate-to-severely painful orthopedic surgery as measured with a numeric rating scale.

Specific Aim 2: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and degree of sensory deficit during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.

Hypothesis 2: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with increased sensory deficit the day following moderate-to-severely painful orthopedic surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at the time of the data-collection phone call.

  Eligibility

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

Inclusion Criteria:

  • Undergoing surgery with a planned popliteal-sciatic perineural catheter for postoperative analgesia
  • Expected postoperative pain to be at least moderate in severity the day following surgery (often not adequately treatable with oral analgesics alone)
  • Age 18 years or older

Exclusion Criteria:

  • Pregnancy
  • Inability to communicate wiht the investigators and hospital staff
  • Incarceration
  • Current chronic opioid use (daily opioid equivalent of >10mg oxycodone for more than the previous four weeks)
  • History of alcohol or opioid abuse
  • Neuropathy in the surgical extremity
  • Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00876681

Locations
United States, California
UCSD Medical Center
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, San Diego
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Ilfeld, M.D., M.S./ Principal Investigator, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00876681     History of Changes
Other Study ID Numbers: Popliteal Catheter: US vs. NS
Study First Received: April 3, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Catheter
Ultrasound-guidance
Nerve Stimulation
Electrical stimulation
nerve block
UCSD
Orthopedic surgery
Foot/ankle pain
Foot/ankle numbness
Popliteal-Sciatic Catheters

Additional relevant MeSH terms:
Hypesthesia
Pain, Postoperative
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain

ClinicalTrials.gov processed this record on July 22, 2014