MedPath

Memantine and Postoperative Pain

Phase 4
Terminated
Conditions
Pain
Interventions
Drug: Placebo
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo
MemantineMemantine-
Primary Outcome Measures
NameTimeMethod
24 hr Opioid Consumption24 hr
Secondary Outcome Measures
NameTimeMethod
Pain Scores48 hours

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

Chronic Post-surgical Pain1 month, 3 month, 6 month
Opioid Related Side Effects0-24 h

Number of participants with postoperative nausea and vomiting.

Opioid Related Side Effects: Pruritus0-24 h

Number of participants who experienced pruritus.

HyperalgesiaWithin 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 Satisfaction48 hours

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

Trial Locations

Locations (1)

Duke University

🇺🇸

Durham, North Carolina, United States

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