Memantine for Post-Operative Pain Control

Pain, Post-operative Clinical Trial

Official title:

Memantine for Post-Operative Pain Control

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01041313
• Other study ID #: 35063-A
• Secondary ID: NAM-MD-63
• Status: Unknown status
• Phase: Phase 4
• First received: December 29, 2009
• Last updated: June 25, 2010
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2010
• Source: University of Washington
• Contact: Lydia Stout, BA
• Phone: 206-914-9253
• Email: lstout[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Post-operative
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in numerical ratings on pain diaries as outpatients (pre and post surgery)		For 1 week pre-surgery, through 2 weeks post-surgery
Primary	Daily pain numerical ratings at rest and with movement as inpatients.		Immediately post-surgery until discharge (2-3 days)
Primary	Total opiate dose via patient controlled IV hydromorphone		Post-surgery day 1
Primary	Oxycodone dose taken prn		Post-surgery day 2 through 3 months.
Secondary	Treatment group differences in side effects (nausea, itching, sedation, urinary retention following foley catheter discontinuation)		One week pre-surgery through 3 months post-surgery
Secondary	Changes in cognitive function, assessed with Digit-Symbol Substitution Test and Trail Making Test B		One week pre-surgery, immediately pre-surgery, and post-surgery days 1, 2, 3
Secondary	Changes in pain and quality of life questionnaire responses (SF-McGill-2, Brief Pain Questionnaire, SF-36 v2)		One week pre-surgery through 3 months post-surgery, particularly as outpatient