Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02826317 |
| Other study ID # |
14.02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
July 5, 2016 |
| Last updated |
July 7, 2016 |
| Start date |
January 2015 |
| Est. completion date |
June 2016 |
Study information
| Verified date |
July 2016 |
| Source |
Rennes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
France: Ethics Committee |
| Study type |
Observational
|
Clinical Trial 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 (5,6).
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.
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 (5,6).
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 patient's 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 D0/D2 DN4≥ 4/10 and M1/M2 DN4≥ 4/10, 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.
