Phantom Limb PainPLATANCT01626755
Prevention of Phantom Limb Pain After Transtibial Amputation
A study testing Sciatic name block in people with Phantom Limb Pain and Chronic Pain, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in 5 countries.
Trial summary
Phantom limb pain following amputation is a major problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain, Chronic Pain, Prevention
- What is being tested?
- Sciatic name block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Aug 2013to Apr 2017
- Phase
- Interventional
- 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
- patients undergoing elective transtibial amputation for peripheral vascular disease
- age over 18 years
- American Society of Anaesthesiology status II to IV
Who cannot join
- contraindication to peripheral regional anesthesia
- psychiatric disease
- pregnancy or breastfeeding status
- amputation for tumour surgery
- traumatic amputation
- inability to give written and informed consent.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Netherlands4 sites
Academic Medical Center, University of Amsterdam
Amsterdam, North Holland, 1105AZ
Westfriesgasthuis
Hoorn, North Holland
Canisius Wilhelmus Ziekenhuis
Nijmegen
Erasmus Medical Center
Rotterdam, North Holland
Austria2 sites
Innsbruck Medical University Hospital
Innsbruck, Tyrol, 6020
General Hospital Klagenfurt
Klagenfurt, Carinthia
United States1 site
Massachusetts General Hospital, Dept. of Anesthesiology, Perioperative and Pain Medicine
Boston, Massachusetts, 02115
About this study
Official title: Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA) - Randomized, Double-blind, Controlled, Multi-center Trial Comparing Optimized Intravenous Pain Control vs Optimized Intravenous Pain Control Plus Nerve Block.
Phantom limb pain following amputation is a major problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. There is some evidence that optimized perioperative pain control is effective in preventing phantom limb pain, but the potential added role of regional anesthesia has not been defined.
Objective:
Read more
The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease compared to optimized intravenous pain therapy.
Study design:
Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All patients will receive standard optimized intravenous anesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group will receive additional infusion of local anesthetic via a sciatic nerve catheter placed under ultrasound guidance.
Main outcome of this study:
Point prevalence of chronic phantom limb pain after 12 months.
Read the detailed description
Rationale:
Phantom limb pain following amputation is a major clinical problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. There is some evidence that optimized perioperative pain control is effective in preventing phantom limb pain, but the potential added role of regional anesthesia has not been defined.
Objective:
The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease compared to optimized intravenous pain therapy.
Study design:
Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All patients will receive standard optimized intravenous anesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group will receive additional infusion of local anesthetic via a sciatic nerve catheter placed under ultrasound guidance.
Study population:
Patients undergoing elective transtibial amputation for peripheral vascular disease at one of the participating centres, ASA status II to IV.
Intervention:
Infusion of local anesthetic via sciatic nerve catheter placed under ultrasound guidance.
Main study parameter/endpoint:
Point prevalence of chronic phantom limb pain after 12 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All patients, regardless of group allocation, will receive optimalized intravenous pain treatment. The aim of this study is to assess whether additional regional anesthesia (ultrasound-guided sciatic nerve block) can decrease the incidence of phantom limb pain. The working hypothesis is that patients undergoing intervention treatment (optimized intravenous therapy plus nerve block) are expected to feature a decreased incidence of phantom limb pain at 12 months, in addition to improved perioperative analgesia.
The administration of both optimalized intravenous pain treatment and peripheral nerve blockade is routine clinical practice for many procedures on the lower leg, including amputation. The risk of this intervention can be described as very low. In control patients, the sciatic catheter will be used for rescue pain treatment.
- Conditions
- Phantom Limb Pain, Chronic Pain, Prevention
- Being tested
- Sciatic name block
- Keywords
- Phantom limb pain, Chronic pain, Amputation, Peripheral vascular disease
- Medical subject headings
- Phantom Limb, Chronic Pain, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic name blockProcedure or surgery
Ultrasound-guided sciatic nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | Optimized intravenous pain treatment during surgery and for 7 days postoperatively.
Definition: strong opioid patient-controlled analgesia, non-opioids, ketamine intravenously.
Sciatic nerve block: infusion of local anesthetic. Receives: Procedure: Sciatic name block |
| Control | Active comparator | Optimized intravenous pain treatment during surgery and for 7 days postoperatively.
Definition: strong opioid patient-controlled analgesia, non-opioids, ketamine intravenously.
Sciatic nerve block: saline infusion. Receives: Procedure: Sciatic name block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence of chronic phantom limb pain
Measured: 12 months after amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startAug 2013
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Lack of funding and recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Anaesthesiology
- Responsible party
- Principal investigator, Philipp Lirk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Markus Hollmann, MD PhD, Study chair, Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The NetherlandsPhilipp Lirk, MD PhD, Principal investigator, Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626755
- Sponsor's protocol ID
- PLATA
- Acronym
- PLATA
- Status last verified
- Oct 2017
- First submitted
- 21 Jun 2012
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ypsilantis E, Tang TY. Pre-emptive analgesia for chronic limb pain after amputation for peripheral vascular disease: a systematic review. Ann Vasc Surg. 2010 Nov;24(8):1139-46. doi: 10.1016/j.avsg.2010.03.026.
PubMed 20800987Rathmell JP, Kehlet H. Do we have the tools to prevent phantom limb pain? Anesthesiology. 2011 May;114(5):1021-4. doi: 10.1097/ALN.0b013e31820fc80d. No abstract available.
PubMed 21383618
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA) - Randomized, Double-blind, Controlled, Multi-center Trial Comparing Optimized Intravenous Pain Control vs Optimized Intravenous Pain Control Plus Nerve Block.
- ClinicalTrials.gov ID
- NCT01626755
- Acronym / sponsor ID
- PLATA / PLATA
- Conditions
- Phantom Limb Pain, Chronic Pain, Prevention
- Keywords
- Phantom limb pain, Chronic pain, Amputation, Peripheral vascular disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding and recruitment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- European Society of Anaesthesiology
- Study start
- Aug 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 25 Jun 2012 (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.
Phantom limb pain following amputation is a major problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. There is some evidence that optimized perioperative pain control is effective in preventing phantom limb pain, but the potential added role of regional anesthesia has not been defined.
Objective:
The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease compared to optimized intravenous pain therapy.
Study design:
Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All patients will receive standard optimized intravenous anesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group will receive additional infusion of local anesthetic via a sciatic nerve catheter placed under ultrasound guidance.
Main outcome of this study:
Point prevalence of chronic phantom limb pain after 12 months.
Detailed description
Rationale:
Phantom limb pain following amputation is a major clinical problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. There is some evidence that optimized perioperative pain control is effective in preventing phantom limb pain, but the potential added role of regional anesthesia has not been defined.
Objective:
The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease compared to optimized intravenous pain therapy.
Study design:
Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All patients will receive standard optimized intravenous anesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group will receive additional infusion of local anesthetic via a sciatic nerve catheter placed under ultrasound guidance.
Study population:
Patients undergoing elective transtibial amputation for peripheral vascular disease at one of the participating centres, ASA status II to IV.
Intervention:
Infusion of local anesthetic via sciatic nerve catheter placed under ultrasound guidance.
Main study parameter/endpoint:
Point prevalence of chronic phantom limb pain after 12 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All patients, regardless of group allocation, will receive optimalized intravenous pain treatment. The aim of this study is to assess whether additional regional anesthesia (ultrasound-guided sciatic nerve block) can decrease the incidence of phantom limb pain. The working hypothesis is that patients undergoing intervention treatment (optimized intravenous therapy plus nerve block) are expected to feature a decreased incidence of phantom limb pain at 12 months, in addition to improved perioperative analgesia.
The administration of both optimalized intravenous pain treatment and peripheral nerve blockade is routine clinical practice for many procedures on the lower leg, including amputation. The risk of this intervention can be described as very low. In control patients, the sciatic catheter will be used for rescue pain treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Experimental | Procedure: Sciatic name blockOptimized intravenous pain treatment during surgery and for 7 days postoperatively. Definition: strong opioid patient-controlled analgesia, non-opioids, ketamine intravenously. Sciatic nerve block: infusion of local anesthetic. |
| Control | Active comparator | Procedure: Sciatic name blockOptimized intravenous pain treatment during surgery and for 7 days postoperatively. Definition: strong opioid patient-controlled analgesia, non-opioids, ketamine intravenously. Sciatic nerve block: saline infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing elective transtibial amputation for peripheral vascular disease
- age over 18 years
- American Society of Anaesthesiology status II to IV
Key exclusion criteria (6 listed)
- contraindication to peripheral regional anesthesia
- psychiatric disease
- pregnancy or breastfeeding status
- amputation for tumour surgery
- traumatic amputation
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 |
|---|---|---|
| Sciatic name blockUltrasound-guided sciatic nerve block. | Procedure or surgery | Control, Nerve block |
Primary outcome
Point prevalence of chronic phantom limb pain
Time frame: 12 months after amputation
Results and safety
The study was stopped early (reason given: Lack of funding and recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Background: PubMed 20800987Ypsilantis E, Tang TY. Pre-emptive analgesia for chronic limb pain after amputation for peripheral vascular disease: a systematic review. Ann Vasc Surg. 2010 Nov;24(8):1139-46. doi: 10.1016/j.avsg.2010.03.026.
- Background: PubMed 21383618Rathmell JP, Kehlet H. Do we have the tools to prevent phantom limb pain? Anesthesiology. 2011 May;114(5):1021-4. doi: 10.1097/ALN.0b013e31820fc80d. No abstract available.
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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.
Markus Hollmann, MD PhD study chair
Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
Philipp Lirk, MD PhD principal investigator
Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sciatic name block in people with Phantom Limb Pain and Chronic Pain, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in 5 countries.
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 6 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, Austria, United States, Belgium, Spain. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of funding and recruitment.). 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?
Point prevalence of chronic phantom limb pain (time frame: 12 months after amputation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01626755, which also lists 2 linked publications.
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 27 Oct 2017.