Upper-extremity SurgeryPhase 4NCT00876746
Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks
A Phase 4 study testing Supraclavicular vs. Infraclavicular ropivicaine infusion in people with Upper-extremity Surgery and Post-operative Pain, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper-extremity Surgery, Post-operative Pain
- What is being tested?
- Supraclavicular vs. Infraclavicular ropivicaine infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Upper-extremity Surgery, Post-operative Pain
- Being tested
- Supraclavicular vs. Infraclavicular ropivicaine infusion
- Keywords
- Pain, surgery, catheter, nerve block, supraclavicular, infraclavicular, UCSD, moderate-to-severe pain, Supraclavicular catheter, Infraclavicular catheter
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular vs. Infraclavicular ropivicaine infusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusion |
| 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. Receives: Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (6)
Opioids consumed by patient each day after surgery as reported to study staff.
Measured: 3 days
Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff.
Measured: 3 days
Infusion side effects (shortness of breath) as reported to study staff.
Measured: 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
Measured: 3 days
Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff.
Measured: 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper-extremity SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Brian M Ilfeld, M.D., M.S., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876746
- Sponsor's protocol ID
- Supra / Infra Catheters
- Status last verified
- Apr 2009
- First submitted
- 3 Apr 2009
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks
- ClinicalTrials.gov ID
- NCT00876746
- Acronym / sponsor ID
- Supra / Infra Catheters
- Conditions
- Upper-extremity Surgery, Post-operative Pain
- Keywords
- Pain, surgery, catheter, nerve block, supraclavicular, infraclavicular, UCSD, moderate-to-severe pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Supraclavicular | Active comparator | Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusionPatients 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. |
| 2. Infraclavicular | Active comparator | Procedure: Supraclavicular vs. Infraclavicular ropivicaine infusionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraclavicular vs. Infraclavicular ropivicaine infusionPatients 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. | Procedure or surgery | 1. Supraclavicular, 2. Infraclavicular |
Primary outcome
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
6 secondary outcomes
Opioids consumed by patient each day after surgery as reported to study staff.
Time frame: 3 days
Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff.
Time frame: 3 days
Infusion side effects (shortness of breath) as reported to study staff.
Time frame: 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
Time frame: 3 days
Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff.
Time frame: 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.
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian M Ilfeld, M.D., M.S. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supraclavicular vs. Infraclavicular ropivicaine infusion in people with Upper-extremity Surgery and Post-operative Pain, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2010.