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HyperalgesiaPhase 1/2NCT00188383

Effects of N-Methyl-D-Aspartate (NMDA)-Receptor Antagonism on Hyperalgesia, Opioid Use, and Pain After Radical Prostatectomy

A Phase 1/2 study testing Amantadine in people with Hyperalgesia and Pain, run by University Health Network, Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary aim is to determine whether perioperative NMDA-receptor antagonism has differential effects on postoperative pain, hyperalgesia and morbidity in younger and older patients. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Hyperalgesia, Pain, Prostate Cancer
What is being tested?
Amantadine
How many people
132 participants
Where
1 siteCanada
Study dates
Jan 2004to Dec 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to read and write English;
  • Age 18-59 or >= 60 years;
  • American Society of Anesthesiologists Class 1 to 3;
  • Scheduled for elective radical prostatectomy;
  • Body weight between 50-110 kg, body mass index (BMI) <= 30.

Who cannot join

  • Significant central nervous system (CNS), respiratory, cardiac, hepatic, renal or endocrine dysfunction and/or any significant sequelae;
  • Contraindications, allergies to, and/or past adverse reactions to opioid analgesics, amantadine or nonsteroidal anti-inflammatory drugs (NSAIDS);
  • Current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) Axis I disorder or cognitive dysfunction or history of this within the last year;
  • History of epilepsy or other seizures;
  • History of chronic pain of at least 6 months duration;
  • History of long term opioid use for chronic pain of at least 6 months duration;
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  • History of long term use of amantadine or other antiparkinsonian drug;
  • Ingestion of antitussive medication (dextromethorphan) within the 48 hours before surgery;
  • History of alcohol or drug dependency/abuse of at least 6 months duration

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • University Health Network

    Toronto, Ontario, M5G 2C4

    Lucia Gagliese, PhD, 416-340-4800 ext. 4296, lucia.gagliese@uhn.on.ca

    Lucia Gagliese, PhD

    Recruiting

Other trials in Canada

About this study

Official title: Effects of NMDA-Receptor Antagonism on Hyperalgesia, Opioid Use, and Pain After Radical Prostatectomy in Young and Elderly Patients

The primary aim is to determine whether perioperative NMDA-receptor antagonism has differential effects on postoperative pain, hyperalgesia and morbidity in younger and older patients. In order to achieve this aim, the researchers propose to conduct the first randomized, double-blind placebo-controlled study designed to investigate age differences in the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine) in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors and the pharmacological properties of amantadine and morphine will be measured to control for, and clarify, their contribution to the differences found.

The specific objectives of the study are to:

  1. investigate the effects of perioperative NMDA receptor blockade on postoperative hyperalgesia, pain and analgesic consumption in young and elderly men
  2. assess age differences in the intensity and course of secondary hyperalgesia after surgery
Read the detailed description

The immediate postoperative period is associated with spontaneous pain and hyperalgesia, i.e., increased pain response (both intensity and duration) to normally painful stimuli following tissue injury or damage.

The development and maintenance of secondary hyperalgesia depend on complex plastic changes in spinal cord dorsal horn cells after peripheral injury or damage. Afferent impulses signaling the damage are carried to the dorsal horn by slowly conducting, unmyelinated C-fibres. C-fibres release glutamate which acts at three receptor types: metabotropic, kainate/AMPA and NMDA. NMDA receptor activation, through a complex cascade of intracellular events, results in dorsal horn neuron hyperexcitability or central sensitization. These cells have increased spontaneous activity, decreased threshold, increased response to afferent input, prolonged afterdischarge to repeated stimulation, and an expansion of receptive fields. Central sensitization is expressed behaviorally as secondary hyperalgesia and contributes to prolonged postoperative pain. It also may trigger pathological reorganization of neural circuitry leading to the development of chronic postsurgical pain. Through these processes, tissue injury may have profound effects on the CNS that long outlast the injury.

In animal models of pain, NMDA agonists induce central sensitization and hyperalgesia whereas antagonists decrease or prevent hyperalgesia. In humans, NMDA-receptor antagonism decreases secondary hyperalgesia subsequent to experimentally-induced pain.

Perioperative administration of NMDA antagonists, that is, before, during and after surgery, may be the ideal intervention to block the initiation and maintenance of central sensitization. Several studies have found that this intervention reduces postoperative hyperalgesia, pain, and analgesic use; however, others have not found these effects. This is not surprising given the variability across studies in factors such as surgical procedure, extent and nature of tissue damage, duration of surgery, pharmacokinetics of the agent(s) tested, and intraoperative and postoperative analgesia. Nonetheless, the weight of the evidence suggests that preventing or minimizing central sensitization reduces pain and analgesic requirements.

Co-administration of NMDA antagonists and opioids has been advocated as an effective approach. The combination of morphine and amantadine should reduce postoperative pain by inducing analgesia through actions on opioid-mediated receptor systems and by reducing hyperalgesia via NMDA receptor-mediated events . The combination also should produce fewer opioid-related adverse effects due to the anticipated opioid-sparing effect. The present proposal describes the first direct comparison of perioperative NMDA receptor blockade coupled with intra- and post-operative opioid administration in young and elderly patients. In order to minimize the influence of other perioperative factors on the outcome variables, all patients will undergo the same surgical procedure and anesthetic protocol. Furthermore, factors that cannot readily be standardized (e.g., surgical duration, mood) will be measured and controlled for statistically. This increases the internal validity of the proposed study and our ability to detect age and drug effects.

Being tested
Amantadine
Keywords
Hyperalgesia, Quantitative Sensory Testing, Pain, Opioid use, Elderly
Medical subject headings
Hyperalgesia, Pain, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmantadineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To investigate the effects of perioperative NMDA receptor blockade on postoperative hyperalgesia, pain and analgesic consumption in young and elderly men

Secondary outcomes (1)
  1. To assess age differences in the intensity and course of secondary hyperalgesia after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startJan 2004
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Early clinical test
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
132 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00188383
Sponsor's protocol ID
94759-200109MCT
Status last verified
Sep 2005
First submitted
9 Sep 2005
Last updated
14 Mar 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Amantadine in people with Hyperalgesia and Pain, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lucia Gagliese, PhD (416-340-4800 ext. 4296, lucia.gagliese@uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate the effects of perioperative NMDA receptor blockade on postoperative hyperalgesia, pain and analgesic consumption in young and elderly men. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2006.

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Clinical Trial NCT00188383 | AzTrials