Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia
This study is currently recruiting participants.
Verified March 2013 by University of California, San Diego
Sponsor:
University of California, San Diego
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01229696
First received: October 27, 2010
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Popliteal Nerve Block Foot Surgery Ankle Surgery Popliteal Bifurcation |
Procedure: Catheter Placed At Bifurcation Procedure: Catheter Placed 5cm Above Bifurcation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia |
Resource links provided by NLM:
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- Average Pain [ Time Frame: 1 Day following surgery ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- Analgesic Use [ Time Frame: 1 day following surgery ] [ Designated as safety issue: No ]Total oral opioid use since surgery and total IV analgesics if any.
- Sleep Disturbances [ Time Frame: 1 day following surgery ] [ Designated as safety issue: No ]Total number of times patient woke due to pain the night following surgery.
- Infusion Side Effects [ Time Frame: 1 day following surgery ] [ Designated as safety issue: No ]Numbness of foot and toes on a 0-10 scale where 0=no numbness and 10=complete numbness.
- Satisfaction of pain control [ Time Frame: 1 day following surgery ] [ Designated as safety issue: No ]Patients will give an answer on a 0-10 scale where 0=completely unsatisfied wiht pain control and 10=completely satisfied with pain control.
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Procedure: Catheter Placed 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.
|
|
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.
|
Procedure: Catheter Placed 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.
|
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.
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229696
Contacts
| Contact: Brian M Ilfeld, M.D., M.S. | 619-543-5742 | bilfeld@ucsd.edu |
Locations
| United States, California | |
| UCSD Medical Centers (Hillcrest and Thornton) | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Brian M Ilfeld, M.D., M.S. 619-543-5742 bilfeld@ucsd.edu | |
| Principal Investigator: Brian M Ilfeld, M.D., M.S. | |
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
| Responsible Party: | Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01229696 History of Changes |
| Other Study ID Numbers: | Popliteal Bifurcation |
| Study First Received: | October 27, 2010 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Popliteal UCSD Postoperative pain Foot surgery Ankle surgery |
Popliteal Catheter Popliteal Nerve Block Lower extremity surgery Bifurcation Catheter Insertion Site |
ClinicalTrials.gov processed this record on June 17, 2013