Memantine for Post-Operative Pain Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01041313
First received: December 29, 2009
Last updated: June 25, 2010
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Daily pain numerical ratings at rest and with movement as inpatients. [ Time Frame: Immediately post-surgery until discharge (2-3 days) ] [ Designated as safety issue: No ]
  • Total opiate dose via patient controlled IV hydromorphone [ Time Frame: Post-surgery day 1 ] [ Designated as safety issue: No ]
  • Oxycodone dose taken prn [ Time Frame: Post-surgery day 2 through 3 months. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 29, 2009
Last Updated: June 25, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014