Memantine and Postoperative Pain

Memantine for Postoperative Analgesia

Memantine is associated with improvement in pain relief after surgery.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Memantine

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
• Enrollment (Actual): 77
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; BID
Active Comparator: Memantine	Drug: Memantine; 20 mg, BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24 hr Opioid Consumption	24 hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Pain score (0=no pain, 10= worst possible pain)	48 hours
Opioid Related Side Effects	Number of participants with postoperative nausea and vomiting.	0-24 h
Opioid Related Side Effects: Pruritus	Number of participants who experienced pruritus.	0-24 h
Hyperalgesia	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.	Within 48 h
Patient Satisfaction	Number of participants who reported "very satisfied" or "somewhat satisfied"	48 hours
Chronic Post-surgical Pain		1 month, 3 month, 6 month

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: February 15, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: Pro00019279