Memantine for Postoperative Analgesia
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Duke University
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- 24 hr Opioid Consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Memantine
Intervention: Memantine (Drug)
Placebo
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
24 hr Opioid Consumption
Time Frame: 24 hr
Secondary Outcomes
- Pain Scores(48 hours)
- Chronic Post-surgical Pain(1 month, 3 month, 6 month)
- Opioid Related Side Effects(0-24 h)
- Opioid Related Side Effects: Pruritus(0-24 h)
- Patient Satisfaction(48 hours)
- Hyperalgesia(Within 48 h)