Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research study is to determine the relative times for perineural catheter placement with the use of ultrasound versus electrical stimulation. The perineural catheter is placed next to the nerves through which local anesthetic is placed to provide pain control following surgery. This study may determine if one method is associated with increased success rate and patient comfort.
Primary Specific Aim: To determine if the relative times for perineural catheter placement with the use of ultrasound versus electrical stimulation.
Hypothesis: Compared with the use of electrical stimulation, the use of ultrasound guidance when inserting a perineural catheter is associated with a decreased time of placement.
Secondary Specific Aim: To determine if other possible benefits of perineural catheter placement associated with the use of ultrasound guidance versus electrical stimulation.
Hypothesis: Compared with the use of electrical stimulation, the use of ultrasound guidance when inserting a perineural catheter is associated with an increased surgical block success rate and catheter-placement success rate, as well as decreased patient discomfort and incidence of venous puncture.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Ultrasound | Active Comparator | Ultrasound is randomly chosen by use of a computer program. The time for catheter placement will begin with the ultrasound probe touches the patient. Patients will be asked their discomfort on a 0-10 scale (0=no discomfort and 10=worst discomfort imaginable) and will be called the next day by the research staff. |
|
| 2. Electrical Stimulation | Active Comparator | Nerve Stimulation (electrical stimulation) is randomly chosen using a computer program. Time of placement begins when the catheter-placement first touches the patient. After catheter placement patient is asked their discomfort on a 0-10 scale (0=no discomfort and 10=worst discomfort imaginable) and called the day after surgery by the research staff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perineural mepivicaine catheter placed via ultrasound or electrical stimulation | Procedure | Patients will be randomized to one of two groups: catheter placement via ultrasound or nerve stimulation. Placement of the catheter will be timed by research staff and discomfort level asked after placement of catheter. If the catheter is not placed by the randomized method within 15 minutes, the practitioner my switch to the alternate method. Patients will be called the morning after surgery by research staff to assess discomfort levels. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measurement will be the time of placement for a perineural catheter using either ultrasound-guided method or electrical stimulation method. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and discomfort as assessed by a 0-10 scale (0=no pain/discomfort and 10=worst pain/discomfort imaginable) by the research coordinator. | After catheter placement and Postoperative day 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian M Ilfeld, M.D., M.S. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | United States |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |