Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks - Full Text View

Sponsors and Collaborators:	University of California, San Diego University of California San Diego, Department of Anesthesiology
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00876746

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 IV

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Supraclavicular: Active Comparator 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.
2. Infraclavicular: Active Comparator 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

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

Contacts

Contact: Brian M Ilfeld, M.D., M.S.

619-543-5742

bilfeld@ucsd.edu

Locations

United States, California
UCSD Medical Center	Recruiting
San Diego, California, United States, 92103
Contact: Brian M Ilfeld, M.D., M.S. 619-543-5742 bilfeld@ucsd.edu
Principal Investigator: Brian M Ilfeld, M.D., M.S.

Sponsors and Collaborators

University of California, San Diego

University of California San Diego, Department of Anesthesiology

Investigators

Principal Investigator:

Brian M Ilfeld, M.D., M.S.

University of California, San Diego

More Information

No publications provided

Responsible Party:	University of California, San Diego, Department of Anesthesiology ( Brian Ilfeld, M.D., M.S./ Principal Investigator )
Study ID Numbers:	Supra / Infra Catheters
Study First Received:	April 3, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00876746 History of Changes
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

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Postoperative Complications
Pain
Pain, Postoperative

ClinicalTrials.gov processed this record on May 07, 2009