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:
University of California, San Diego
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
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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
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 May 21, 2013