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Memantine and Postoperative Pain

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ClinicalTrials.gov Identifier: NCT01032759
Recruitment Status : Terminated
First Posted : December 15, 2009
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
Memantine is associated with improvement in pain relief after surgery.

Condition or disease Intervention/treatment Phase
Pain Drug: Memantine Drug: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine for Postoperative Analgesia
Study Start Date : December 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Memantine Drug: Memantine
20 mg, BID
Placebo Comparator: Placebo
Placebo
Drug: Placebo
BID



Primary Outcome Measures :
  1. 24 hr Opioid Consumption [ Time Frame: 24 hr ]

Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: 48 hours ]
    Pain score (0=no pain, 10= worst possible pain)

  2. Opioid Related Side Effects [ Time Frame: 0-24 h ]
    Number of participants with postoperative nausea and vomiting.

  3. Opioid Related Side Effects: Pruritus [ Time Frame: 0-24 h ]
    Number of participants who experienced pruritus.

  4. Hyperalgesia [ Time Frame: 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.

  5. Patient Satisfaction [ Time Frame: 48 hours ]
    Number of participants who reported "very satisfied" or "somewhat satisfied"

  6. Chronic Post-surgical Pain [ Time Frame: 1 month, 3 month, 6 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032759


Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01032759     History of Changes
Other Study ID Numbers: Pro00019279
First Posted: December 15, 2009    Key Record Dates
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents