Foot Surgery Clinical Trial
Official title:
Ultrasound-Guided Continuous Sciatic Nerve Blocks: Popliteal Versus Subgluteal Catheters
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCSD Medical Center, Thornton | La Jolla | California |
United States | UCSD Medical Center Hillcrest | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle Strength (MVIC) of the hamstring muscles | 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 90ยบ | 08:00-09:00 morning after surgery as a percentage of baseline | No |
Secondary | Sensory Effect | 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. | 08:00-09:00 morning after surgery | No |
Secondary | Pain Scores | Surgical pain scores both average and worse as collected by nursing staff; and also the average and worse pain during the primary endpoint measurement | from leaving the PACU until 08:00 the morning after surgery | No |
Secondary | Sleep Disturbances | Total number of times patient woke in the night due to surgical pain. | recorded at 08:00-09:00 the morning after surgery for the previous night | No |
Secondary | Total Infusion | Total infusiond duration in time and volume and total number of boluses delivered via catheter. | recorded at 08:00-09:00 the morning following Surgery | No |
Secondary | Anesthetic Leakage | Leakage from the catheter site noted by patient. | recorded at 08:00-09:00 the morning following Surgery | No |
Secondary | analgesic consumption | Hourly analgesic consumption. | end of PACU stay until 08:00-09:00 the morning following surgery | No |
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