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Memantine and Postoperative Pain

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Duke University

Status and phase

Terminated
Phase 4

Conditions

Pain

Treatments

Drug: Placebo
Drug: Memantine

Study type

Interventional

Funder types

Other

Identifiers

NCT01032759
Pro00019279

Details and patient eligibility

About

Memantine is associated with improvement in pain relief after surgery.

Full 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.

Enrollment

77 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

77 participants in 2 patient groups, including a placebo group

Memantine
Active Comparator group
Treatment:
Drug: Memantine
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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