Recruiting

Memantine

Sponsor:

University of Washington

Code:

NCT01041313

Conditions

Pain, Post-operative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Memantine

Placebo

Study Details

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).

Conditions

Pain, Post-operative

Study ID

NCT01041313

Start date

Jan, 2010

Status verified date

Jun, 2010

Completion date

Sep, 2011

Anticipated

Primary completion date

Jun, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Opiate Naive

Subjects who have not taken opiate medication in previous 6 weeks before surgery

active comparator: Opiate tolerant

Subjects who have taken opiate medications for the 6 weeks before surgery

Interventions

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.

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 ]
  • 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. ]

Central Contacts and Locations

Central contacts

Lydia Stout, BA

206-914-9253lstout@uw.edu

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Lydia Stout, BA

206-914-9253lstout@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Jun 29, 2010

Last verified

Jun, 2010

Keywords

  • Adjuvants, pharmaceuticals
  • Receptors, N-Methyl-D-Aspartate
  • Drug tolerance
  • Pain Measurement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2010-06-29.