Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

Study Overview
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Brief Summary
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This research study is to determine if the insertion site of a perineural catheter or tiny tube placed next to the nerves that go to the part of the body (hand or arm) having surgery, affects the amount of pain relief that is experienced after surgery. Catheters will be placed in either the supraclavicular or infraclavicular location.

Detailed Description
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To determine if a particular perineural local anesthetic catheter location (supraclavicular or infraclavicular) will maximize postoperative analgesia, minimize oral opioid requirements, minimize sleep disturbances resulting from postoperative pain, and maximize patient satisfaction.

Official Title
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Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

Conditions
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Upper-extremity Surgery, Post-operative Pain

Intervention / Treatment
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* Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older unilateral, upper (at or distal to the elbow) extremity orthopedic surgery with moderate-to-severe postoperative pain expected patients already agree to and want a continuous brachial plexus block for postoperative analgesia Exclusion Criteria: patients who have difficulty understanding the study protocol or caring for the infusion pump/catheter system patients who have any known contraindication to study medications insulin-dependent diabetes mellitus neuropathy of any etiology in the affected extremity contraindication to regional blockade (e.g. clotting deficiency) any known acute or chronic hepatic or renal insufficiency or failure any incision site outside of the catheter-effected area chronic opioid use history of opioid abuse obesity pregnancy incarceration inability to communicate with the investigators and hospital staff

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Supraclavicular<br>Patients will be randomized to placement of a nerve block in the supraclavicular position. After the catheter has been placed, sensory and motor deficit will be assessed and following surgery, for the next three days, the patient will be contacted by research staff to assess pain scores and other outcome measures. | Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusion<br>* Patients will be randomized to one of two groups: nerve blocks in the supraclavicular location or the infraclavicular location. Following surgery the patient will be called by study staff to assess pain scores, sleep disturbances, infusion side effects, feeling in fingers and other study outcomes.<br>|
| Active Comparator: 2. Infraclavicular<br>Patients will be randomized to placement of a nerve block in the infraclavicular position. After the catheter has been placed, sensory and motor deficit will be assessed and following surgery, for the next three days, the patient will be contacted by research staff to assess pain scores and other outcome measures. | Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusion<br>* Patients will be randomized to one of two groups: nerve blocks in the supraclavicular location or the infraclavicular location. Following surgery the patient will be called by study staff to assess pain scores, sleep disturbances, infusion side effects, feeling in fingers and other study outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical pain as measured on a 0-10 scale where 0=no pain and 10=worst imaginable pain. The values for the two different catheter locations will be compared to see which site is optimal for catheter placement. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioids consumed by patient each day after surgery as reported to study staff. |  | 3 days | 
| Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff. |  | 3 days | 
| Infusion side effects (shortness of breath) as reported to study staff. |  | 3 day | 
| Satisfaction with pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied, as reported to study staff at time of daily phone calls |  | 3 days | 
| Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff. |  | 3 days | 
| Catheter site discomfort, leakage at catheter site, and catheter related pain on the 0-10 rating scale, where 0=no pain and 10=worst imaginable pain, as reported to study staff during phone calls. |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, surgery, catheter, nerve block, supraclavicular, infraclavicular, UCSD, moderate-to-severe pain, Supraclavicular catheter, Infraclavicular catheter