Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00876746
First received: April 3, 2009
Last updated: June 14, 2010
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Upper-extremity Surgery
Post-operative Pain
Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Opioids consumed by patient each day after surgery as reported to study staff. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Infusion side effects (shortness of breath) as reported to study staff. [ Time Frame: 3 day ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876746

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
  More Information

No publications provided

Responsible Party: Brian Ilfeld, M.D., M.S./ Principal Investigator, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00876746     History of Changes
Other Study ID Numbers: Supra / Infra Catheters
Study First Received: April 3, 2009
Last Updated: June 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Pain
surgery
catheter
nerve block
supraclavicular
infraclavicular
UCSD
moderate-to-severe pain
Supraclavicular catheter
Infraclavicular catheter

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014