- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00413257
Effects of Nefopam on Hyperalgesia After Cardiac Surgery (NefalCard)
Study of the Effects of Nefopam on Hyperalgesia Following Sternotomy in Cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction :
Postoperative pain is not only a consequence of the surgical lesion, but is also related to sensitization processes that appear in peripheral and central nerves. This sensitization induce clinically hyperalgesia and allodynia. From an experimental viewpoint it comes mainly from a central activation of NMDA receptors in neurons that conduct the nociceptive message.
Recent studies have shown that high-dose opioids were able, via NMDA receptors, to enhance postoperative hyperalgesia and to increase pain scores and morphine consumption after surgery. Nevertheless per operative use of opioid is still necessary to avoid per operative stress and systemic consequence of the surgical stimulation.
Some drugs (ketamine, nitrous oxide…) succeeded in reducing postoperative hyperalgesia and pains scores and acute morphine tolerance. They also were able to decrease pain chronicization.
Nefopam, well known as an analgesic since the 80's, presents both analgesic and anti hyperalgesic properties as lately demonstrated in experimental trials. Nevertheless these anti hyperalgesic properties have never been evaluated in humans scheduled for cardiac surgery. Nefopam administration could reduce acute morphine tolerance and could enhance postoperative pain management by reducing sensitization processes and hyperalgesia.
Objective :
The main purpose of this clinical trial will be to evaluate in patients scheduled for cardiac surgery with sternotomy the nefopam effects on the nociceptive threshold evaluated with dynamic Von Frey mechanical stimulation.
The secondary objectives will evaluate static hyperalgesia, postoperative pain scores, morphine consumption, cognitive functions, and development of chronic pain and dysesthesia.
Methods :
Prospective, randomized, double-blind study that will compare three parallel groups that will receive the same per operative anesthesia except for the nefopam doses.
Group 1: nefopam infusion will start before the surgical incision, at the induction time of anesthesia and will be continued until postoperative H48. Group 2: nefopam administration will start at the end of the surgery and will be continued until postoperative H48. Group 3: control group that will receive a placebo from the induction time of anesthesia until H48. All patients will receive postoperatively morphine infusion following the Patient Controlled Analgesia concept.
Number of patients to be included : 90 Duration of the study : 2 years Start : second semester of 2006
Expected result :
Reduction of the extend of hyperalgesia around the wound evaluated with dynamic Von Frey mechanical stimulation more than 20%.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Pessac, France, 33604
- Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magellan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 55-75 years old
- ASA score: 1-3
- Patients scheduled for Cardiac surgery with median sternotomy for : single valve replacement or Bentall or Benson or Tyron David surgery, single or multiple Cardiac Artery Bypass Grafting (CABG) , combined surgery (valve replacement + CABG) without preoperative risk of postoperative complications
- Informed consent obtained from the patient
Exclusion Criteria:
- Drug or alcohol abuse history
- Analgesic or opioid consumption within the 12hs preceding the surgery
- Chronic use of analgesic drugs or history of chronic pain
- Convulsion or epilepsy history
- Glaucoma history
- Disability to understand morphine PCA use
- Allergy to nefopam
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
nefopam infusion will start before the surgical incision, at the induction time of anesthesia and will be continued until postoperative H48
|
0,3mg/kg IV bolus preoperative and 65 µg/kg/h during H48 postoperative
|
Experimental: 2
nefopam administration will start at the end of the surgery and will be continued until postoperative H48
|
bolus Néfopam (0,3mg/kg) during 10 min at the end of surgery and 65 µg/kg/h during postoperative H48
|
Placebo Comparator: 3
control group that will receive a placebo from the induction time of anesthesia until H48
|
bolus NaCl during 10 min at the end of surgery and during postoperative H48
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Nociceptive threshold evaluated with Von Frey mechanical dynamic stimulation. This will start 10cm far from the wound on a perpendicular line to the wound and will be conducted by 1cm step to the wound until the patient explains the stimulation
Time Frame: H 24
|
H 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
static hyperalgesia with Von Frey stimulation 1cm far from the middle of the wound, on the right side of the wound.
Time Frame: 1, 2, 4 and 7 days after intervention
|
1, 2, 4 and 7 days after intervention
|
Morphine consumption
Time Frame: over the 48 H postoperative
|
over the 48 H postoperative
|
Pain scores evaluation
Time Frame: Acute pain (1, 2, 4 and 7 days after intervention) / Chronic Pain (3, 6 and 12 month)
|
Acute pain (1, 2, 4 and 7 days after intervention) / Chronic Pain (3, 6 and 12 month)
|
Cognitive functions evaluation
Time Frame: 1, 2, 4 and 7 days after intervention
|
1, 2, 4 and 7 days after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Antoine BENARD, Dr, University Hospital, Bordeaux
- Principal Investigator: Philippe RICHEBE, Dr, University Hospital, Bordeaux
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Disease Attributes
- Sensation Disorders
- Somatosensory Disorders
- Pain, Postoperative
- Chronic Pain
- Chronic Disease
- Hyperalgesia
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Nefopam
Other Study ID Numbers
- 7813 (Other Identifier: CTEP)
- 2005-033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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