Back to resultsOptimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks
Primary Purpose
Upper-extremity Surgery, Post-operative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Supraclavicular vs. Infraclavicular ropivicaine infusion
Sponsored by
About this trial
This is an interventional treatment trial for Upper-extremity Surgery focused on measuring Pain, surgery, catheter, nerve block, supraclavicular, infraclavicular, UCSD, moderate-to-severe pain, Supraclavicular catheter, Infraclavicular catheter
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
Sites / Locations
- UCSD Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1. Supraclavicular
2. Infraclavicular
Arm Description
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.
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.
Outcomes
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.
Secondary Outcome Measures
Opioids consumed by patient each day after surgery as reported to study staff.
Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff.
Infusion side effects (shortness of breath) as reported to study staff.
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
Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff.
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.
Full Information
NCT ID
NCT00876746
First Posted
April 3, 2009
Last Updated
June 14, 2010
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00876746
Brief Title
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
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper-extremity Surgery, Post-operative Pain
Keywords
Pain, surgery, catheter, nerve block, supraclavicular, infraclavicular, UCSD, moderate-to-severe pain, Supraclavicular catheter, Infraclavicular catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1. Supraclavicular
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2. Infraclavicular
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Supraclavicular vs. Infraclavicular ropivicaine infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Opioids consumed by patient each day after surgery as reported to study staff.
Time Frame
3 days
Title
Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff.
Time Frame
3 days
Title
Infusion side effects (shortness of breath) as reported to study staff.
Time Frame
3 day
Title
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
Title
Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff.
Time Frame
3 days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Ilfeld, M.D., M.S.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
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Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks
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