Ignite Creation Date:
2024-05-06 @ 8:47 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02826317
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2016-07-05
Brief Title:
Neuropathic Evaluation of Postoperative Pain
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Evaluation du caractère Neuropathique Des Douleurs Post opératoires Enquête 2 Jours DN4-SFAR
Status:
COMPLETED
Status Verified Date:
2016-07
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:
DN4-SFAR
Brief Summary:
Chronic postsurgical pain CPSP is defined by pain persisting longer than 2 months after surgery 1 Its incidence varies from 10 to 50 in the literature 2 A high proportion of CPSP is neuropathic CPSNP 4 Postoperative pain is traditionally classified as nociceptive pain and the more intense is this pain on a numeric pain scale NPS higher are the risks of pain chronicization and the duration of the severe pain is longer 56 However acute neuropathic pain ANP can be present in the postoperative setting However data on the prevalence of ANP immediately after surgery are scarce and no screening tool has been validated so far in this setting Therefore the first objective of this multicenter observational study is to prospectively describe the incidence of APSNP in a large population using the DN4 questionnaire The second objective of our study is to confirm the hypothetic link between APSNP and CPSNP at 1 and 2 months after surgery in a large population It is hypothesized that the systematic use of the DN4 questionnaire in postoperative could help detect patients at risk of CPSNP
Detailed Description:
Chronic postsurgical pain CPSP is defined by pain persisting longer than 2 months after surgery 1 Its incidence varies from 10 to 50 in the literature 2 A high proportion of CPSP is neuropathic CPSNP 4 Postoperative pain is traditionally classified as nociceptive pain and the more intense is this pain on a numeric pain scale NPS higher are the risks of pain chronicization and the duration of the severe pain is longer 56 However acute neuropathic pain ANP can be present in the postoperative setting However data on the prevalence of ANP immediately after surgery are scarce and no screening tool has been validated so far in this setting Therefore the first objective of this multicenter observational study is to prospectively describe the incidence of APSNP in a large population using the DN4 questionnaire The second objective of our study is to confirm the hypothetic link between APSNP and CPSNP at 1 and 2 months after surgery in a large population It is hypothesized that the systematic use of the DN4 questionnaire in postoperative could help detect patients at risk of CPSNP
Methods
Investigators and centers will be recruited through the SFAR French Society of Anesthesiology and Intensive Care research network The study will take place during the same 2 consecutive days in all the centers in France Each center agreed to include as many patients as they could during this period All adult patients undergoing inpatient scheduled or urgent surgery are eligible The study is solely observational and does not interfere with the patients care Preoperative assessment will consist on collecting demographic data age sex body mass index type of surgery as well as the presence preoperative chronic pain and its localization preoperative opioid gabapentin or pregabalin consumption In postoperative we will collect the following data type of anesthesia intra operative ketamine administration type and total dose of opioid administered during surgery Pain will be evaluated at least 2 hours after the surgery within the same day D0 and then at day 2 D2 1 M1 and 2 months M2 after the surgery Pain will be assessed using a 10-point NPS If NPS 0 neuropathic pain will be diagnosed on the basis of DN4 questionnaire NCPSP is defined by NPS 0 and positive DN4 DN4 4 10 11 APSNP and CPSNP are defined by D0D2 DN4 410 and M1M2 DN4 410 respectively The preoperative and immediate postoperative day 0 and day 2 data will be collected by one investigator in each center The latter data 1 and 2 months after the surgery will be assessed over the phone by research nurses
Methods
Investigators and centers will be recruited through the SFAR French Society of Anesthesiology and Intensive Care research network The study will take place during the same 2 consecutive days in all the centers in France Each center agreed to include as many patients as they could during this period All adult patients undergoing inpatient scheduled or urgent surgery are eligible The study is solely observational and does not interfere with the patients care Preoperative assessment will consist on collecting demographic data age sex body mass index type of surgery as well as the presence preoperative chronic pain and its localization preoperative opioid gabapentin or pregabalin consumption In postoperative we will collect the following data type of anesthesia intra operative ketamine administration type and total dose of opioid administered during surgery Pain will be evaluated at least 2 hours after the surgery within the same day D0 and then at day 2 D2 1 M1 and 2 months M2 after the surgery Pain will be assessed using a 10-point NPS If NPS 0 neuropathic pain will be diagnosed on the basis of DN4 questionnaire NCPSP is defined by NPS 0 and positive DN4 DN4 4 10 11 APSNP and CPSNP are defined by D0D2 DN4 410 and M1M2 DN4 410 respectively The preoperative and immediate postoperative day 0 and day 2 data will be collected by one investigator in each center The latter data 1 and 2 months after the surgery will be assessed over the phone by research nurses
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