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

Primary Purpose

Postoperative Pain, Foot Numbness

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Popliteal catheter placed via ultrasound or electrical stimulation
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Catheter, Ultrasound-guidance, Nerve Stimulation, Electrical stimulation, nerve block, UCSD, Orthopedic surgery, Foot/ankle pain, Foot/ankle numbness, Popliteal-Sciatic Catheters

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1. Ultrasound

2. Electrical Stimulation

Arm Description

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.

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.

Outcomes

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).

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 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.
Catheter placement success rate as assessed by attending physician who will test for sensory deficit.
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.

Full Information

First Posted
April 3, 2009
Last Updated
October 7, 2009
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00876681
Brief Title
Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks
Official Title
Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Foot Numbness
Keywords
Catheter, Ultrasound-guidance, Nerve Stimulation, Electrical stimulation, nerve block, UCSD, Orthopedic surgery, Foot/ankle pain, Foot/ankle numbness, Popliteal-Sciatic Catheters

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Ultrasound
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2. Electrical Stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Popliteal catheter placed via ultrasound or electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Catheter placement success rate as assessed by attending physician who will test for sensory deficit.
Time Frame
30 minutes
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Ilfeld, M.D., M.S.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20700680
Citation
Mariano ER, Loland VJ, Sandhu NS, Bishop ML, Lee DK, Schwartz AK, Girard PJ, Ferguson EJ, Ilfeld BM. Comparative efficacy of ultrasound-guided and stimulating popliteal-sciatic perineural catheters for postoperative analgesia. Can J Anaesth. 2010 Oct;57(10):919-26. doi: 10.1007/s12630-010-9364-7. Epub 2010 Aug 11.
Results Reference
derived

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

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