Clinical trial NCT00876746: Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks
Official title: Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper-extremity Surgery
Post-operative Pain
Keywords: Pain
surgery
catheter
nerve block
supraclavicular
infraclavicular
UCSD
moderate-to-severe pain
Supraclavicular catheter
Infraclavicular catheter
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 days
Secondary outcomes:
measure: Opioids consumed by patient each day after surgery as reported to study staff.
timeFrame: 3 days
measure: Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff.
timeFrame: 3 days
measure: Infusion side effects (shortness of breath) as reported to study staff.
timeFrame: 3 day
measure: 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
timeFrame: 3 days
measure: Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff.
timeFrame: 3 days
measure: 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.
timeFrame: 3 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: