Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain; Upper-extremity Surgery
• Intervention / Treatment: Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusion

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1. Supraclavicular; 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; 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.
Active Comparator: 2. Infraclavicular; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 6, 2009
• First Posted (Estimate): April 7, 2009

Study Record Updates

• Last Update Posted (Estimate): June 15, 2010
• Last Update Submitted That Met QC Criteria: June 14, 2010
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Pain; surgery; nerve block; catheter; UCSD; supraclavicular; infraclavicular; moderate-to-severe pain; Supraclavicular catheter; Infraclavicular catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Supra / Infra Catheters