Memantine and Postoperative Pain

Pain Clinical Trial

Official title:

Memantine for Postoperative Analgesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01032759
• Other study ID #: Pro00019279
• Status: Terminated
• Phase: Phase 4
• First received: December 14, 2009
• Last updated: February 15, 2016
• Start date: December 2009
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Memantine is associated with improvement in pain relief after surgery.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Memantine
20 mg, BID
• Placebo
BID

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hr Opioid Consumption		24 hr	Yes
Secondary	Pain Scores	Pain score (0=no pain, 10= worst possible pain)	48 hours	No
Secondary	Opioid Related Side Effects	Number of participants with postoperative nausea and vomiting.	0-24 h	No
Secondary	Opioid Related Side Effects: Pruritus	Number of participants who experienced pruritus.	0-24 h	No
Secondary	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	No
Secondary	Patient Satisfaction	Number of participants who reported "very satisfied" or "somewhat satisfied"	48 hours	No
Secondary	Chronic Post-surgical Pain		1 month, 3 month, 6 month	No