Memantine and Postoperative Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01032759
First received: December 14, 2009
Last updated: July 1, 2014
Last verified: July 2014
  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:
  • Pain scores [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: December 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (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
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 Recruiting
Durham, North Carolina, United States, 27710
Contact: Ashraf Habib, MD    919-668-6266    ashraf.habib@duke.edu   
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01032759     History of Changes
Other Study ID Numbers: Pro00019279
Study First Received: December 14, 2009
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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 August 27, 2014