Pain, Post-operativePhase 4NCT01041313
Memantine for Post-Operative Pain Control
A Phase 4 study testing Memantine in people with Pain, Post-operative, run by University of Washington at 1 site in United States.
Trial summary
Pain is a common element of surgery. Opiates (morphine, oxycodone, hydrocodone, methadone, fentanyl) are very helpful in decreasing pain after surgery. Unfortunately, with repeated use opiates lose their effectiveness, such that patients need to utilize more opiates to achieve adequate pain relief - a phenomenon… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Post-operative
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery for total hip replacement, knee replacement OR lumbar spinal fusion
- Taking no opiate medication OR taking opiate medication for at least 6 weeks
Who cannot join
- History of alcohol or drug abuse
- Clinical diagnosis of Alzheimer's Disease
- Prior adverse reaction to memantine
- Severe renal impairment (creatinine clearance <30 ml/min)
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Lydia Stout, BA, 206-914-9253, lstout@uw.edu
About this study
Pain is a common element of surgery. Opiates (morphine, oxycodone, hydrocodone, methadone, fentanyl) are very helpful in decreasing pain after surgery. Unfortunately, with repeated use opiates lose their effectiveness, such that patients need to utilize more opiates to achieve adequate pain relief - a phenomenon called tolerance. Sometimes tolerance to a pain reliever's effects can develop in just a few hours. It is thought that activation of the N-methyl d-aspartate (NMDA) receptor, a "switch" found on the surface of nerves, is partially responsible for opiate tolerance. Memantine is a medication that limits the activity of NMDA receptors in the brain and spinal cord. It has been used for years to help patients with Alzheimer's Disease. In this study, we will study the effects of memantine when combined with opiate medications to see whether it can increase the effectiveness of opiates for pain after surgery and reduce the side effects caused by opiates (e.g., sedation, nausea, itching).
- Conditions
- Pain, Post-operative
- Being tested
- Memantine, Placebo
- Keywords
- Adjuvants, pharmaceuticals, Receptors, N-Methyl-D-Aspartate, Drug tolerance, Pain Measurement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda
7 days prior to surgery, start taking 5mg memantine daily; 4 days prior to surgery, increase dose to 5mg twice daily; 2 days prior to surgery, increase dose to 10mg in the morning, and 5 mg in the evening; on the day of surgery, increase dose to 10mg twice daily, and continue on this dose until 14 days after surgery.
PlaceboDrug
7 days prior to surgery, start taking one placebo tablet daily; 4 days prior to surgery, increase dose to one placebo tablet twice daily; 2 days prior to surgery, increase dose to 2 placebo tablets in the morning, and one placebo tablet in the evening; on the day of surgery, increase dose to 2 placebo tablets in the morning and 1 placebo tablet in the evening. On the first day after surgery through 14 days after surgery, take 1 placebo tablet twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Opiate Naive | Active comparator | Subjects who have not taken opiate medication in previous 6 weeks before surgery Receives: Drug: Memantine; Drug: Placebo |
| Opiate tolerant | Active comparator | Subjects who have taken opiate medications for the 6 weeks before surgery Receives: Drug: Memantine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in numerical ratings on pain diaries as outpatients (pre and post surgery)
Measured: For 1 week pre-surgery, through 2 weeks post-surgery
Daily pain numerical ratings at rest and with movement as inpatients.
Measured: Immediately post-surgery until discharge (2-3 days)
Total opiate dose via patient controlled IV hydromorphone
Measured: Post-surgery day 1
Oxycodone dose taken prn
Measured: Post-surgery day 2 through 3 months.
Secondary outcomes (3)
Treatment group differences in side effects (nausea, itching, sedation, urinary retention following foley catheter discontinuation)
Measured: One week pre-surgery through 3 months post-surgery
Changes in cognitive function, assessed with Digit-Symbol Substitution Test and Trail Making Test B
Measured: One week pre-surgery, immediately pre-surgery, and post-surgery days 1, 2, 3
Changes in pain and quality of life questionnaire responses (SF-McGill-2, Brief Pain Questionnaire, SF-36 v2)
Measured: One week pre-surgery through 3 months post-surgery, particularly as outpatient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, Post-operativeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Gregory Terman, MD, PhD, Principal investigator, University of Washington Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041313
- Sponsor's protocol ID
- 35063-A
- Other IDs
- NAM-MD-63
- Status last verified
- Jun 2010
- First submitted
- 29 Dec 2009
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Grande LA, O'Donnell BR, Fitzgibbon DR, Terman GW. Ultra-low dose ketamine and memantine treatment for pain in an opioid-tolerant oncology patient. Anesth Analg. 2008 Oct;107(4):1380-3. doi: 10.1213/ane.0b013e3181733ddd.
PubMed 18806055
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine for Post-Operative Pain Control
- ClinicalTrials.gov ID
- NCT01041313
- Acronym / sponsor ID
- 35063-A
- Conditions
- Pain, Post-operative
- Keywords
- Adjuvants, pharmaceuticals, Receptors, N-Methyl-D-Aspartate, Drug tolerance, Pain Measurement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 31 Dec 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.
Pain is a common element of surgery. Opiates (morphine, oxycodone, hydrocodone, methadone, fentanyl) are very helpful in decreasing pain after surgery. Unfortunately, with repeated use opiates lose their effectiveness, such that patients need to utilize more opiates to achieve adequate pain relief - a phenomenon called tolerance. Sometimes tolerance to a pain reliever's effects can develop in just a few hours. It is thought that activation of the N-methyl d-aspartate (NMDA) receptor, a "switch" found on the surface of nerves, is partially responsible for opiate tolerance. Memantine is a medication that limits the activity of NMDA receptors in the brain and spinal cord. It has been used for years to help patients with Alzheimer's Disease. In this study, we will study the effects of memantine when combined with opiate medications to see whether it can increase the effectiveness of opiates for pain after surgery and reduce the side effects caused by opiates (e.g., sedation, nausea, itching).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opiate Naive | Active comparator | Drug: Memantine, Drug: PlaceboSubjects who have not taken opiate medication in previous 6 weeks before surgery |
| Opiate tolerant | Active comparator | Drug: Memantine, Drug: PlaceboSubjects who have taken opiate medications for the 6 weeks before surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgery for total hip replacement, knee replacement OR lumbar spinal fusion
- Taking no opiate medication OR taking opiate medication for at least 6 weeks
Key exclusion criteria (5 listed)
- History of alcohol or drug abuse
- Clinical diagnosis of Alzheimer's Disease
- Prior adverse reaction to memantine
- Severe renal impairment (creatinine clearance <30 ml/min)
- Inability to give informed consent
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 |
|---|---|---|
| MemantineAlso: Namenda7 days prior to surgery, start taking 5mg memantine daily; 4 days prior to surgery, increase dose to 5mg twice daily; 2 days prior to surgery, increase dose to 10mg in the morning, and 5 mg in the evening; on the day of surgery, increase dose to 10mg twice daily, and continue on this dose until 14 days after surgery. | Drug | Opiate Naive, Opiate tolerant |
| Placebo7 days prior to surgery, start taking one placebo tablet daily; 4 days prior to surgery, increase dose to one placebo tablet twice daily; 2 days prior to surgery, increase dose to 2 placebo tablets in the morning, and one placebo tablet in the evening; on the day of surgery, increase dose to 2 placebo tablets in the morning and 1 placebo tablet in the evening. On the first day after surgery through 14 days after surgery, take 1 placebo tablet twice daily. | Drug | Opiate Naive, Opiate tolerant |
Primary outcome
Change in numerical ratings on pain diaries as outpatients (pre and post surgery)
Time frame: For 1 week pre-surgery, through 2 weeks post-surgery
Daily pain numerical ratings at rest and with movement as inpatients.
Time frame: Immediately post-surgery until discharge (2-3 days)
Total opiate dose via patient controlled IV hydromorphone
Time frame: Post-surgery day 1
Oxycodone dose taken prn
Time frame: Post-surgery day 2 through 3 months.
3 secondary outcomes
Treatment group differences in side effects (nausea, itching, sedation, urinary retention following foley catheter discontinuation)
Time frame: One week pre-surgery through 3 months post-surgery
Changes in cognitive function, assessed with Digit-Symbol Substitution Test and Trail Making Test B
Time frame: One week pre-surgery, immediately pre-surgery, and post-surgery days 1, 2, 3
Changes in pain and quality of life questionnaire responses (SF-McGill-2, Brief Pain Questionnaire, SF-36 v2)
Time frame: One week pre-surgery through 3 months post-surgery, particularly as outpatient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
- Background: PubMed 18806055Grande LA, O'Donnell BR, Fitzgibbon DR, Terman GW. Ultra-low dose ketamine and memantine treatment for pain in an opioid-tolerant oncology patient. Anesth Analg. 2008 Oct;107(4):1380-3. doi: 10.1213/ane.0b013e3181733ddd.
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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.
Gregory Terman, MD, PhD principal investigator
University of Washington Department of Anesthesiology and Pain Medicine
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 Memantine in people with Pain, Post-operative, run by University of Washington 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 2 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: status not confirmed, as of the sponsor's last update on 29 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lydia Stout, BA (206-914-9253, lstout@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in numerical ratings on pain diaries as outpatients (pre and post surgery) (time frame: For 1 week pre-surgery, through 2 weeks post-surgery). The study lists 4 primary outcomes in all. 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 NCT01041313, which also lists 1 linked publication.
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 29 Jun 2010.