Memantine and Postoperative Pain
- Registration Number
- NCT01032759
- Lead Sponsor
- Duke University
- Brief Summary
Memantine is associated with improvement in pain relief after surgery.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 77
- Male
- Age 18 to 75 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Memantine Memantine -
- Primary Outcome Measures
Name Time Method 24 hr Opioid Consumption 24 hr
- Secondary Outcome Measures
Name Time Method Pain Scores 48 hours Pain score (0=no pain, 10= worst possible pain)
Chronic Post-surgical Pain 1 month, 3 month, 6 month Opioid Related Side Effects 0-24 h Number of participants with postoperative nausea and vomiting.
Opioid Related Side Effects: Pruritus 0-24 h Number of participants who experienced pruritus.
Hyperalgesia 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.
Patient Satisfaction 48 hours Number of participants who reported "very satisfied" or "somewhat satisfied"
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States