Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Memantine is associated with improvement in pain relief after surgery.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine | Active Comparator |
| |
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | 20 mg, BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hr Opioid Consumption | 24 hr |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
Not provided
77 participants signed consent, 63 participants were randomized
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Memantine | Memantine: 20 mg, BID |
| FG001 | Placebo | Placebo Placebo: BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Memantine | Memantine: 20 mg, BID |
| BG001 | Placebo | Placebo Placebo: BID |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Pain Scores | Pain score (0=no pain, 10= worst possible pain) | Participants who completed the 48 hour assessment. | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Memantine | Memantine: 20 mg, BID |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TIA | Nervous system disorders | Non-systematic Assessment | Transient ischemic attack |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashraf Habib | Duke University Medical Center | 9196686266 | habib001@dm.duke.edu |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
BID |
|
| 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 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 24 hr Opioid Consumption | Participants who completed the 24 hour assessment. | Posted | Mean | Standard Deviation | mg morphine equivalents | 24 hr |
|
|
|
| Secondary | Opioid Related Side Effects | Number of participants with postoperative nausea and vomiting. | Posted | Number | participants | 0-24 h |
|
|
|
| Secondary | Opioid Related Side Effects: Pruritus | Number of participants who experienced pruritus. | Posted | Number | participants | 0-24 h |
|
|
|
| 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. | Number of participants who had this outcome measured and documented | Posted | Mean | Standard Deviation | cm2 | Within 48 h |
|
|
|
| Secondary | Patient Satisfaction | Number of participants who reported "very satisfied" or "somewhat satisfied" | Number of participants who had this outcome reported and documented. | Posted | Number | participants | 48 hours |
|
|
|
| Secondary | Chronic Post-surgical Pain | Data was not collected and therefore not analyzed. | Posted | 1 month, 3 month, 6 month |
|
|
| 1 |
| 32 |
| 0 |
| 32 |
| EG001 | Placebo | Placebo Placebo: BID | 1 | 31 | 1 | 31 |
| Pulmonary embolism | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |