AmputationPhase 4NCT00771862
Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
A Phase 4 study testing perineural ropivicaine in people with Amputation and Phantom Limb Pain, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Phantom Limb Pain, Stump Pain
- What is being tested?
- perineural ropivicaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to 30 May 2017
- 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
- undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively
- currently without phantom limb and/or stump pain in a previously-amputated limb
- ages 18 years or older
- desiring perineural infusion for up to 6 days
- willing to have an ambulatory infusion following hospital discharge
Who cannot join
- hepatic or renal failure
- allergy to the study medications
- pregnancy
- incarceration
- possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.
Read the detailed description
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain.
Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.
Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
- Conditions
- Amputation, Phantom Limb Pain, Stump Pain
- Being tested
- perineural ropivicaine
- Keywords
- pain, amputation, phantom limb, stump pain, catheter, nerve block, peripheral nerve block, ucsd, post-amputation phantom limb or stump pain
- Medical subject headings
- Phantom Limb, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineural ropivicaineProcedure or surgery
Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.
| Study group | Role | What they receive |
|---|---|---|
| 1. standard care | Placebo comparator | 1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion. Receives: Procedure: perineural ropivicaine |
| 2: experimental care | Active comparator | 4-5 days of perineural ropivacaine 0.4% infusion. Receives: Procedure: perineural ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups.
Measured: Week 4
Secondary outcomes (3)
Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)
Measured: Preoperative, then days 3, 8, 28, 84, and 365
Emotional Functioning: Beck Depression Inventory
Measured: Preoperative, then days 28 and 365
The incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2008
- Primary completion30 May 2017
- Study completion30 May 2017
Why it stopped: Could not secure funding to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian Ilfeld, M.D., M.S., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771862
- Sponsor's protocol ID
- Phantom Pain Prevention PILOT
- Status last verified
- Mar 2018
- First submitted
- 14 Oct 2008
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
- ClinicalTrials.gov ID
- NCT00771862
- Acronym / sponsor ID
- Phantom Pain Prevention PILOT
- Conditions
- Amputation, Phantom Limb Pain, Stump Pain
- Keywords
- pain, amputation, phantom limb, stump pain, catheter, nerve block, peripheral nerve block, ucsd
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not secure funding to complete the study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Oct 2008
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 15 Oct 2008 (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.
The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.
Detailed description
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain.
Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.
Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. standard care | Placebo comparator | Procedure: perineural ropivicaine1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion. |
| 2: experimental care | Active comparator | Procedure: perineural ropivicaine4-5 days of perineural ropivacaine 0.4% infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively
- currently without phantom limb and/or stump pain in a previously-amputated limb
- ages 18 years or older
- desiring perineural infusion for up to 6 days
- willing to have an ambulatory infusion following hospital discharge
Key exclusion criteria (5 listed)
- hepatic or renal failure
- allergy to the study medications
- pregnancy
- incarceration
- possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion
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 |
|---|---|---|
| perineural ropivicaineSubjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h. | Procedure or surgery | 1. standard care, 2: experimental care |
Primary outcome
The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups.
Time frame: Week 4
3 secondary outcomes
Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)
Time frame: Preoperative, then days 3, 8, 28, 84, and 365
Emotional Functioning: Beck Depression Inventory
Time frame: Preoperative, then days 28 and 365
The incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Could not secure funding to complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
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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 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 perineural ropivicaine in people with Amputation and Phantom Limb 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Mar 2018. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Could not secure funding to complete the study.). Results are not available in the source record.
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?
The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups. (time frame: Week 4). 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 19 Mar 2018.