Memantine for Post-Operative Pain Control

NCT01041313 | Unknown Phase 4

• 2 other identifiers: 35063-ANAM-MD-63
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in numerical ratings on pain diaries as outpatients (pre and post surgery)

  For 1 week pre-surgery, through 2 weeks post-surgery

• Daily pain numerical ratings at rest and with movement as inpatients.

  Immediately post-surgery until discharge (2-3 days)

• Total opiate dose via patient controlled IV hydromorphone

  Post-surgery day 1

• Oxycodone dose taken prn

  Post-surgery day 2 through 3 months.

Secondary Outcomes (3)

• Treatment group differences in side effects (nausea, itching, sedation, urinary retention following foley catheter discontinuation)

  One week pre-surgery through 3 months post-surgery

• 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

• 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

Study Arms (2)

Opiate Naive

ACTIVE COMPARATOR

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

Drug: Memantine; Drug: Placebo

Opiate tolerant

ACTIVE COMPARATOR

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

Drug: Memantine; Drug: Placebo

Interventions

Memantine DRUG

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.

Also known as: Namenda

Opiate Naive; Opiate tolerant

Placebo DRUG

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.

Opiate Naive; Opiate tolerant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Related 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.

  PMID: 18806055 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Memantine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gregory Terman, MD, PhD

  University of Washington Department of Anesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia Stout, BA

CONTACT

206-914-9253; lstout@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 31, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

US (1)