Memantine and Postoperative Pain

• ClinicalTrials.gov Identifier: NCT01032759
• Recruitment Status: Terminated
• First Posted: December 15, 2009
• Results First Posted: March 14, 2016
• Last Update Posted: March 14, 2016
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

Memantine is associated with improvement in pain relief after surgery.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Memantine; Drug: Placebo	Phase 4

Detailed Description:

This prospective, randomized, controlled trial will investigate whether perioperative memantine has a postoperative analgesic effect following radical retropubic prostatectomy (RRP). 100-110 patients scheduled to undergo RRP at Duke will be assessed preoperatively for allodynia using Von Frey filaments, then stratified into two groups based on the presence or absence of allodynia. Patients in each group will then be randomized to receive either memantine 20 mg or placebo 30-60 minutes preoperatively, followed on postoperative day 1 with either memantine 10 mg in the morning and 10 mg in the evening for memantine patients, or placebo at the same intervals for placebo patients. Data such as morphine consumption, patient satisfaction and pain scores, opioid-related side effects, and the area of hyperalgesia around the surgical incision will be recorded for the initial 48 hours postoperatively, and patient satisfaction with their postoperative analgesia will be assessed after 1 week. At 1, 3, and 6 months postoperatively, patients will be asked about the presence and intensity of any persistent pain related to surgery.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Memantine for Postoperative Analgesia
• Study Start Date: December 2009
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Memantine	Drug: Memantine; 20 mg, BID
Placebo Comparator: Placebo; Placebo	Drug: Placebo; BID

Outcome Measures

Primary Outcome Measures :

1. 24 hr Opioid Consumption [ Time Frame: 24 hr ]

Secondary Outcome Measures :

1. Pain Scores [ Time Frame: 48 hours ]
   Pain score (0=no pain, 10= worst possible pain)
2. Opioid Related Side Effects [ Time Frame: 0-24 h ]
   Number of participants with postoperative nausea and vomiting.
3. Opioid Related Side Effects: Pruritus [ Time Frame: 0-24 h ]
   Number of participants who experienced pruritus.
4. Hyperalgesia [ Time Frame: Within 48 h ]
   Stimulation with a Von Frey hair filament at 396 mN of force will be started from outside the hyperalgesic area, where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a "painful," "sore," or "sharper" feeling occurs will be marked, and the distance to the incision measured. The surface area will be measured in cm2 around the surgical incision.
5. Patient Satisfaction [ Time Frame: 48 hours ]
   Number of participants who reported "very satisfied" or "somewhat satisfied"
6. Chronic Post-surgical Pain [ Time Frame: 1 month, 3 month, 6 month ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male
• Age 18 to 75 years old

Exclusion Criteria:

• Chronic pain conditions or taking regular analgesics
• Taking psychotropic medications
• Parkinson's disease
• Narrow-angle glaucoma
• Known gastroduodenal ulcer
• History of seizure disorder
• Renal insufficiency, as defined by serum creatinine greater than 2 mg/dL
• Liver disease, including liver failure, cirrhosis, or acute hepatitis
• Significant coronary vascular disease or cardiac conduction system disease, as noted by ECG or history of cardiac symptoms, or cardiac ejection fraction less than 30%
• American Society of Anesthesiologists (ASA) score of 4 or higher
• Allergy to ketorolac or memantine

Contacts and Locations

Locations

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01032759
• Other Study ID Numbers: Pro00019279
• First Posted: December 15, 2009
• Results First Posted: March 14, 2016
• Last Update Posted: March 14, 2016
• Last Verified: January 2016

Additional relevant MeSH terms:

Memantine; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents