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Memantine for Post-Operative Pain Control

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Washington.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041313
First Posted: December 31, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by:
University of Washington
  Purpose
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).

Condition Intervention Phase
Pain, Post-operative Drug: Memantine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine for Post-Operative Pain Control

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Opiate Naive
Subjects who have not taken opiate medication in previous 6 weeks before surgery
Drug: Memantine
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.
Other Name: Namenda
Drug: Placebo
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.
Active Comparator: Opiate tolerant
Subjects who have taken opiate medications for the 6 weeks before surgery
Drug: Memantine
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.
Other Name: Namenda
Drug: Placebo
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery for total hip replacement, knee replacement OR lumbar spinal fusion
  • Taking no opiate medication OR taking opiate medication for at least 6 weeks

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041313


Contacts
Contact: Lydia Stout, BA 206-914-9253 lstout@uw.edu

Locations
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Lydia Stout, BA    206-914-9253    lstout@uw.edu   
Sponsors and Collaborators
University of Washington
Forest Laboratories
Investigators
Principal Investigator: Gregory Terman, MD, PhD University of Washington Department of Anesthesiology and Pain Medicine
  More Information

Publications:
Responsible Party: Gregory Terman, MD, PhD, Professor, University of Washington, Department of Anesthesiology and Pain Medicine, Division of Pain Medicine
ClinicalTrials.gov Identifier: NCT01041313     History of Changes
Other Study ID Numbers: 35063-A
NAM-MD-63
First Submitted: December 29, 2009
First Posted: December 31, 2009
Last Update Posted: October 12, 2017
Last Verified: June 2010

Keywords provided by University of Washington:
Adjuvants, pharmaceuticals
Receptors, N-Methyl-D-Aspartate
Drug tolerance
Pain Measurement

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Memantine
Opiate Alkaloids
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents