- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01229696
Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia
April 7, 2016 updated by: Brian M. Ilfeld, MD, MS, University of California, San Diego
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Hypothesis: During a continuous popliteal nerve block, postoperative analgesia will be improved with the perineural catheter tip at the level of the sciatic nerve bifurcation compared to when the catheter tip is 5 cm cephalad/proximal to the bifurcation.
Study Type
Interventional
Enrollment (Anticipated)
150
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
-
-
California
-
San Diego, California, United States, 92103
- UCSD Medical Centers (Hillcrest and Thornton)
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-
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 surgery with a popliteal perineural catheter for postoperative analgesia
- age 18 years or older
Exclusion Criteria:
- 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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: At Bifurcation
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.
|
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.
|
Active Comparator: 5cm Above Bifurcation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Pain
Time Frame: 1 Day following surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesic Use
Time Frame: 1 day following surgery
|
Total oral opioid use since surgery and total IV analgesics if any.
|
1 day following surgery
|
Sleep Disturbances
Time Frame: 1 day following surgery
|
Total number of times patient woke due to pain the night following surgery.
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1 day following surgery
|
Infusion Side Effects
Time Frame: 1 day following surgery
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Numbness of foot and toes on a 0-10 scale where 0=no numbness and 10=complete numbness.
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1 day following surgery
|
Satisfaction of pain control
Time Frame: 1 day following surgery
|
Patients will give an answer on a 0-10 scale where 0=completely unsatisfied wiht pain control and 10=completely satisfied with pain control.
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1 day following surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
October 1, 2010
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
October 27, 2010
First Submitted That Met QC Criteria
October 27, 2010
First Posted (Estimate)
October 28, 2010
Study Record Updates
Last Update Posted (Estimate)
April 11, 2016
Last Update Submitted That Met QC Criteria
April 7, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Popliteal Bifurcation
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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