Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

Phase 4

Completed

• Conditions: Upper-extremity Surgery; Post-operative Pain

• Registration Number: NCT00876746
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2008-12
• Status Verified: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-06-14
• Last Update Posted: 2010-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States