Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413257
Status:
COMPLETED
Last Update Posted:
2010-05-28
First Post:
2006-12-18
Brief Title:
Effects of Nefopam on Hyperalgesia After Cardiac Surgery
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Study of the Effects of Nefopam on Hyperalgesia Following Sternotomy in Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NefalCard
Brief Summary:
Postoperative pain after major surgery is consecutive not only to the nociceptive inputs coming from the surgical lesion but also to peripheral and central neuronal sensitization This lead to postoperative hyperalgesia and allodynia that are enhanced by the per operative use of high opioid doses Anti-NMDA drugs have been reported as able to reduce this sensitization process and then to decrease acute morphine tolerance during the postoperative period Nefopam has been lately shown to combine in experimental trials analgesic and anti hyperalgesic effects The aim of this study is to compare anti-hyperalgesic effects of nefopam given either before incision and continuously for the following 48hours or starting from the end of the surgery and given for 48hours to a control group that would receive placebo for 48hours Postoperative analgesia will be based on morphine PCA Pain scores hyperalgesia allodynia postoperative morphine consumption and development of chronic pain will be the main criteria that will be evaluated during this study
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 80s 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
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 80s 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-033 | None | None | None |