Phantom PainPhase 3NCT02311777
Pre-operative Pregabalin and Ketamine to Prevent Phantom Pain
A Phase 3 study testing Pregabalin and Ketamine in people with Phantom Pain, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually resistant to a wide variety of treatments (1-4). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phantom Pain
- What is being tested?
- Pregabalin and Ketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2015to 20 Sep 2017
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ager 18-65 years old
- Unilateral lower-limb amputations
- Able to understand study procedures
- If on opioids, patient should be on a stable dose for at least one week prior to enrolment.
- Subject with normal renal function (CrCI > 60 mL/min).
Who cannot join
- Cases with only digits amputation
- Current or recent history of alcohol and drug abuse
- Concomitant use of CYP 3A4 medications
- Unstable hypertension
- Abnormal EKG
- Increased intracranial pressure currently or in the past six months
Show all 16Show fewer
- Increased intraocular pressure currently or in the past six months
- Liver disease or AST/ALT ≥ 3 ULN or total bilirubin >2 x ULN
- Poorly controlled psychiatric illness.
- A history of seizure
- Using other anticonvulsant drug
- Renal impairment as determined by clinically significant labs
- Women of childbearing age who either has:
- A positive pregnancy test
- Unprotected heterosexual sex since their previous menses or;
- Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkland Health Hospital System
Dallas, Texas, 750390
UTSW, Parkland Hospital
Dallas, Texas, 75390
About this study
Official title: Effects of Pre-operative Pregabalin and Ketamine to Prevent Development of Phantom Pain in Patients Undergoing Lower Extremity Amputation
Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually resistant to a wide variety of treatments (1-4). Three factors may contribute to the development of persistent, post-amputation PLP by inducing central sensitization at different times relative to surgery: pre-amputation pain, noxious intraoperative stimuli, and acute postoperative pain (5-7).
Investigators hypothesis that pre-amputation period could be important in eliminating Phantom Limb Pain (PLP) in the patients in whom cortical reorganization is not yet established. The reduction of pre-operative pain and prevention of formation of pain memories may eliminate development of PLP by using dual networks treatment strategy. This Phase III, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy of pre-operative pregabalin (lyrica) and ketamine in eliminating phantom limb pain in patients undergoing lower limb amputation.
Read the detailed description
Patients undergoing unilateral lower extremity amputation (n=30) will be randomized in this double blind parallel placebo control clinical trial to evaluate the efficacy of pre-operative pregabalin (lyrica) and ketamine in eliminating phantom limb pain. Patient will receive either pregabalin and ketamine treatment (Group 1) or placebo (Group 2) during pre-operative period approximately 4 days (2-4 days).
Patients will be identified during their anesthesia preoperative clinic or orthopedic inpatient unit (Parkland Hospital or UT Southwestern University Hospital) for the eligibility. Data base (EPIC) will also be used for prescreening of potential subject by reviewing clinic visit daily schedule or operating room schedule. Then patients chart will be reviewed for initial data collection to determine the eligibility of potential subjects with the use of a HIPAA waiver form. Eligible subject will be approached by the study PI, investigators, or research coordinator and written consent obtained prior to any study procedures.
A pregnancy test will be performed before the preoperative treatment start for women in child-bearing age: exceptions include surgically sterile women or women with medically confirmed menopause. Women with a positive pregnancy test or who report unprotected heterosexual sex since their previous menses or not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill) will not enrolled to the study.
Pain will be documented using the visual analog pain score (0=no pain, 10=worst imaginary pain) during preoperative period before the treatment and daily on pain diary and on the day of surgery and during postoperative period at PACU, 24 and 48 hrs. and long-term follow-up 1, 3, and 6 months after the surgery.
Total opioid dose over the 48-h study period will be documented as PCA pump morphine consumption for postoperative first 24 hrs. and postoperative oral opioid usage for 48 hrs. after surgery. Patients will receive a standard general anesthetic for their surgery and postoperative standard of care pain treatment similar to all patients. Study does not limit standard post-operative pain medication.
Long-term analgesic success will be evaluated at 1, 3, and 6 months after surgery. At follow-up period, a pain diary will be used for the patients' self-assessment on pain occurrence, intensity, duration for phantom and stump pain, and documentation of oral analgesic usage. Analgesic medication use and daily pain scores will be documented on pain diary for 1 month period following surgery. At first follow-up visit, patient will be seen in Pain Clinic 1 month after the surgery. Patient will be called from home 3 and 6 months after the surgery for long-term follow-up.
At all-time points, the Self-Rating Depression Scale will be used to assess depression and the patients will complete the Pain-Related Self-Statement Scale (PRSS).
The duration of the involvement in the study will be 6 months.
Randomization:
This is randomized double-blinded placebo controlled clinical trial. Investigational Drug Pharmacy (IDS) will randomize subjects either treatment group or placebo. IDS will dispense the drugs/placebo.
- Conditions
- Phantom Pain
- Being tested
- Pregabalin, Ketamine, Placebo
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Pregabalin will be given orally during preoperative period
KetamineDrug
Also called Ketamine hydrocloride
Ketamine will be given on the surgery day before the anesthesia induction
PlaceboDrug
Also called Placebo pregabalin/placebo ketamine
Placebo will be given orally during preoperative period
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin-ketamine | Active comparator | Pregabalin and ketamine will be given preoperative period Receives: Drug: Pregabalin; Drug: Ketamine |
| Placebo | Placebo comparator | Placebo will be given preoperative period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scores (VAS)
Pain will be evaluated immediate postoperative period and 6 months after surgery
Measured: Postoperaive 6 months
Secondary outcomes (1)
Oral analgesic consumption
Amounts of rescue analgesic use
Measured: 1 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start15 May 2015
- Primary completion20 Sep 2016 (estimated)
- Study completion20 Sep 2017
Why it stopped: Preoperative period is very short time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dawood Nasir, University of Texas Southwestern Medical Center
- Investigators
- Dawood H Nasir, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311777
- Sponsor's protocol ID
- STU 092014-050
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2014
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-operative Pregabalin and Ketamine to Prevent Development of Phantom Pain in Patients Undergoing Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT02311777
- Acronym / sponsor ID
- STU 092014-050
- Conditions
- Phantom Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Preoperative period is very short time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 15 May 2015 (actual)
- Primary completion
- 20 Sep 2016 (estimated)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 8 Dec 2014 (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 (PLP) is as painful sensations located to the missing limb and classified as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually resistant to a wide variety of treatments (1-4). Three factors may contribute to the development of persistent, post-amputation PLP by inducing central sensitization at different times relative to surgery: pre-amputation pain, noxious intraoperative stimuli, and acute postoperative pain (5-7).
Investigators hypothesis that pre-amputation period could be important in eliminating Phantom Limb Pain (PLP) in the patients in whom cortical reorganization is not yet established. The reduction of pre-operative pain and prevention of formation of pain memories may eliminate development of PLP by using dual networks treatment strategy. This Phase III, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy of pre-operative pregabalin (lyrica) and ketamine in eliminating phantom limb pain in patients undergoing lower limb amputation.
Detailed description
Patients undergoing unilateral lower extremity amputation (n=30) will be randomized in this double blind parallel placebo control clinical trial to evaluate the efficacy of pre-operative pregabalin (lyrica) and ketamine in eliminating phantom limb pain. Patient will receive either pregabalin and ketamine treatment (Group 1) or placebo (Group 2) during pre-operative period approximately 4 days (2-4 days).
Patients will be identified during their anesthesia preoperative clinic or orthopedic inpatient unit (Parkland Hospital or UT Southwestern University Hospital) for the eligibility. Data base (EPIC) will also be used for prescreening of potential subject by reviewing clinic visit daily schedule or operating room schedule. Then patients chart will be reviewed for initial data collection to determine the eligibility of potential subjects with the use of a HIPAA waiver form. Eligible subject will be approached by the study PI, investigators, or research coordinator and written consent obtained prior to any study procedures.
A pregnancy test will be performed before the preoperative treatment start for women in child-bearing age: exceptions include surgically sterile women or women with medically confirmed menopause. Women with a positive pregnancy test or who report unprotected heterosexual sex since their previous menses or not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill) will not enrolled to the study.
Pain will be documented using the visual analog pain score (0=no pain, 10=worst imaginary pain) during preoperative period before the treatment and daily on pain diary and on the day of surgery and during postoperative period at PACU, 24 and 48 hrs. and long-term follow-up 1, 3, and 6 months after the surgery.
Total opioid dose over the 48-h study period will be documented as PCA pump morphine consumption for postoperative first 24 hrs. and postoperative oral opioid usage for 48 hrs. after surgery. Patients will receive a standard general anesthetic for their surgery and postoperative standard of care pain treatment similar to all patients. Study does not limit standard post-operative pain medication.
Long-term analgesic success will be evaluated at 1, 3, and 6 months after surgery. At follow-up period, a pain diary will be used for the patients' self-assessment on pain occurrence, intensity, duration for phantom and stump pain, and documentation of oral analgesic usage. Analgesic medication use and daily pain scores will be documented on pain diary for 1 month period following surgery. At first follow-up visit, patient will be seen in Pain Clinic 1 month after the surgery. Patient will be called from home 3 and 6 months after the surgery for long-term follow-up.
At all-time points, the Self-Rating Depression Scale will be used to assess depression and the patients will complete the Pain-Related Self-Statement Scale (PRSS).
The duration of the involvement in the study will be 6 months.
Randomization:
This is randomized double-blinded placebo controlled clinical trial. Investigational Drug Pharmacy (IDS) will randomize subjects either treatment group or placebo. IDS will dispense the drugs/placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin-ketamine | Active comparator | Drug: Pregabalin, Drug: KetaminePregabalin and ketamine will be given preoperative period |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be given preoperative period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ager 18-65 years old
- Unilateral lower-limb amputations
- Able to understand study procedures
- If on opioids, patient should be on a stable dose for at least one week prior to enrolment.
- Subject with normal renal function (CrCI > 60 mL/min).
Key exclusion criteria (16 listed)
- Cases with only digits amputation
- Current or recent history of alcohol and drug abuse
- Concomitant use of CYP 3A4 medications
- Unstable hypertension
- Abnormal EKG
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 |
|---|---|---|
| PregabalinAlso: LyricaPregabalin will be given orally during preoperative period | Drug | Pregabalin-ketamine |
| KetamineAlso: Ketamine hydroclorideKetamine will be given on the surgery day before the anesthesia induction | Drug | Pregabalin-ketamine |
| PlaceboAlso: Placebo pregabalin/placebo ketaminePlacebo will be given orally during preoperative period | Drug | Placebo |
Primary outcome
Visual Analog Pain Scores (VAS)
Time frame: Postoperaive 6 months
Pain will be evaluated immediate postoperative period and 6 months after surgery
1 secondary outcome
Oral analgesic consumption
Time frame: 1 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Phantom Pain
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Lower Limb Amputation
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
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.
Dawood H Nasir, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin and Ketamine in people with Phantom Pain, run by University of Texas Southwestern Medical Center at 2 sites 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 16 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: withdrawn, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Visual Analog Pain Scores (VAS) (time frame: Postoperaive 6 months). 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 Dec 2018.