Clinical trial NCT01041313: Memantine for Post-Operative Pain Control
Official title: Memantine for Post-Operative Pain Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Post-operative
Keywords: Adjuvants, pharmaceuticals
Receptors, N-Methyl-D-Aspartate
Drug tolerance
Pain Measurement
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2009-12-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).


Eligibility 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

Primary outcomes:
measure: Change in numerical ratings on pain diaries as outpatients (pre and post surgery)
timeFrame: For 1 week pre-surgery, through 2 weeks post-surgery
measure: Daily pain numerical ratings at rest and with movement as inpatients.
timeFrame: Immediately post-surgery until discharge (2-3 days)
measure: Total opiate dose via patient controlled IV hydromorphone
timeFrame: Post-surgery day 1
measure: Oxycodone dose taken prn
timeFrame: Post-surgery day 2 through 3 months.
Secondary outcomes:
measure: Treatment group differences in side effects (nausea, itching, sedation, urinary retention following foley catheter discontinuation)
timeFrame: One week pre-surgery through 3 months post-surgery
measure: Changes in cognitive function, assessed with Digit-Symbol Substitution Test and Trail Making Test B
timeFrame: One week pre-surgery, immediately pre-surgery, and post-surgery days 1, 2, 3
measure: Changes in pain and quality of life questionnaire responses (SF-McGill-2, Brief Pain Questionnaire, SF-36 v2)
timeFrame: One week pre-surgery through 3 months post-surgery, particularly as outpatient
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington Department of Anesthesiology and Pain Medicine
name: Gregory Terman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.