Pain
Conditions
Brief summary
Memantine is associated with improvement in pain relief after surgery.
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.
Interventions
DRUGMemantine
20 mg, BID
DRUGPlacebo
BID
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hr Opioid Consumption | 24 hr |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Related Side Effects | 0-24 h | Number of participants with postoperative nausea and vomiting. |
| Opioid Related Side Effects: Pruritus | 0-24 h | Number of participants who experienced pruritus. |
| Pain Scores | 48 hours | Pain score (0=no pain, 10= worst possible pain) |
| Patient Satisfaction | 48 hours | Number of participants who reported very satisfied or somewhat satisfied |
| Chronic Post-surgical Pain | 1 month, 3 month, 6 month | — |
| Hyperalgesia | Within 48 h | 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. |
Countries
United States
Participant flow
Recruitment details
77 participants signed consent, 63 participants were randomized
Participants by arm
| Arm | Count |
|---|---|
| Memantine Memantine: 20 mg, BID | 32 |
| Placebo Placebo
Placebo: BID | 31 |
| Total | 63 |
Baseline characteristics
| Characteristic | Memantine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 7 | 59 years STANDARD_DEVIATION 7 | 59 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 32 participants | 31 participants | 63 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 32 Participants | 31 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 1 / 31 |
| serious Total, serious adverse events | 1 / 32 | 1 / 31 |
Outcome results
Primary
24 hr Opioid Consumption
Time frame: 24 hr
Population: Participants who completed the 24 hour assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine | 24 hr Opioid Consumption | 21.5 mg morphine equivalents | Standard Deviation 3.9 |
| Placebo | 24 hr Opioid Consumption | 18.6 mg morphine equivalents | Standard Deviation 4 |
Secondary
Chronic Post-surgical Pain
Time frame: 1 month, 3 month, 6 month
Population: Data was not collected and therefore not analyzed.
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.
Time frame: Within 48 h
Population: Number of participants who had this outcome measured and documented
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine | Hyperalgesia | 56 cm2 | Standard Deviation 37 |
| Placebo | Hyperalgesia | 54 cm2 | Standard Deviation 36 |
Secondary
Opioid Related Side Effects
Number of participants with postoperative nausea and vomiting.
Time frame: 0-24 h
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Memantine | Opioid Related Side Effects | 19 participants |
| Placebo | Opioid Related Side Effects | 19 participants |
Secondary
Opioid Related Side Effects: Pruritus
Number of participants who experienced pruritus.
Time frame: 0-24 h
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Memantine | Opioid Related Side Effects: Pruritus | 7 participants |
| Placebo | Opioid Related Side Effects: Pruritus | 9 participants |
Secondary
Pain Scores
Pain score (0=no pain, 10= worst possible pain)
Time frame: 48 hours
Population: Participants who completed the 48 hour assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine | Pain Scores | 2.64 units on a scale | Standard Deviation 0.46 |
| Placebo | Pain Scores | 1.71 units on a scale | Standard Deviation 0.4 |
Secondary
Patient Satisfaction
Number of participants who reported very satisfied or somewhat satisfied
Time frame: 48 hours
Population: Number of participants who had this outcome reported and documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Memantine | Patient Satisfaction | 30 participants |
| Placebo | Patient Satisfaction | 25 participants |