Memantine and Postoperative Pain

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-01-31

Brief Summary

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Memantine is associated with improvement in pain relief after surgery.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Memantine

Group Type ACTIVE_COMPARATOR

Memantine

Intervention Type DRUG

20 mg, BID

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

BID

Interventions

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Memantine

20 mg, BID

Intervention Type DRUG

Placebo

BID

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No