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Memantine and Postoperative Pain

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01032759
First received: December 14, 2009
Last updated: February 15, 2016
Last verified: January 2016
  Purpose
Memantine is associated with improvement in pain relief after surgery.

Condition Intervention Phase
Pain
Drug: Memantine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine for Postoperative Analgesia

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 24 hr Opioid Consumption [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain Scores [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Pain score (0=no pain, 10= worst possible pain)

  • Opioid Related Side Effects [ Time Frame: 0-24 h ] [ Designated as safety issue: No ]
    Number of participants with postoperative nausea and vomiting.

  • Opioid Related Side Effects: Pruritus [ Time Frame: 0-24 h ] [ Designated as safety issue: No ]
    Number of participants who experienced pruritus.

  • Hyperalgesia [ Time Frame: Within 48 h ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Number of participants who reported "very satisfied" or "somewhat satisfied"

  • Chronic Post-surgical Pain [ Time Frame: 1 month, 3 month, 6 month ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: December 2009
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Memantine Drug: Memantine
20 mg, BID
Placebo Comparator: Placebo
Placebo
Drug: Placebo
BID

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032759

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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01032759     History of Changes
Other Study ID Numbers: Pro00019279 
Study First Received: December 14, 2009
Results First Received: January 19, 2016
Last Updated: February 15, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 05, 2016