Memantine and Postoperative Pain

Phase 4TerminatedNCT01032759

Duke University77 enrolled

Overview

Memantine is associated with improvement in pain relief after surgery.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

MemantineDRUG

20 mg, BID

PlaceboDRUG

BID

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

24 hr Opioid Consumption

Time frame: 24 hr

Secondary Outcomes

Pain Scores

Pain score (0=no pain, 10= worst possible pain)

Time frame: 48 hours

Opioid Related Side Effects

Number of participants with postoperative nausea and vomiting.

Time frame: 0-24 h

Opioid Related Side Effects: Pruritus

Number of participants who experienced pruritus.

Time frame: 0-24 h

Hyperalgesia

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.

Time frame: Within 48 h

Patient Satisfaction

Number of participants who reported "very satisfied" or "somewhat satisfied"

Time frame: 48 hours

Chronic Post-surgical Pain

Time frame: 1 month, 3 month, 6 month

Data from ClinicalTrials.gov

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