Epidemiologic Multicentre Study of Neuropathic Post-surgical Pain

NCT00812734

Last updated date
Study Location
CHU Clermont-Ferrand
Clermont-Ferrand, , 63003, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuropathic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Agreement to the study

- Scheduled for one of the following surgeries :

- caesarean section

- inguinal hernia repair

- mastectomy

- cholecystectomy under laparoscopy

- saphenectomy (excluding harvesting for coronary bypass)

- sternotomy

- thoracotomy

- knee arthroscopy

- Major over 18 years

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Emergency


- Inability to fill questionnaires


- Unreachable patients

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Advanced Information
Descriptive Information
Brief Title Epidemiologic Multicentre Study of Neuropathic Post-surgical Pain
Official Title Etude épidémiologique Multicentrique Des Douleurs Neuropathiques Post-opératoires
Brief Summary This cohort study aims to know the prevalence at 3 and 6 months after surgery, of persistent pain, as well as to describe the neuropathic features of this pain. It includes more than 3000 patients scheduled for different types of surgery, some of them already known to induce persistent pain, some being frequent procedures with no additional data. Clinical and genetical risk factors will be searched.
Detailed Description

Neuropathic post-surgical pain (NPSP) motivates the consultation of the French Centres for Evaluation and Treatment of Pain in 20 to 35% of the cases. The following table shows the available data of literature about chronic post-surgical pain:

Surgery Prevalence of chronic pain (%) Neuropathic symptoms Mastectomy 22 to 49 Yes Inguinal hernia repair 30 to 63 Yes Sternotomy 28 to 40 Unknown Saphenectomy 5 to 7 Yes Mandibular osteotomy Unknown Yes Cholecystectomy 3 to 20 Unknown Caesarean section 6 Unknown Thoracotomy 50 to 75 Yes Knee arthroscopy Unknown Unknown Rectal amputation 12 to 18 Unknown Limb amputation 60 Yes Endodontic treatment 5 to 13 Unknown

In most of these cases, the mechanism of pain is highly suspected as neuropathic, although the location of the nerve(s) concerned is unclear. However, the clinical features of the pain are often poorly described. In other types of surgery (such as caesarean section or cholecystectomy), the report of chronic pain may be related to the high frequency of these procedures.

The initiation of NPSP can be identified on a time scale (i.e. day of surgery), and can be prospectively expected. This leads to possibility of (i) a better understanding of the evolution of neuropathy following time and (ii) a study of putative preventive (peritraumatic) treatments. Thus, NPSP appears as strongly different from other chronic pain syndromes (such as diabetes mellitus, chemotherapy for cancer or even post-traumatic) for which the time course, mechanisms and psychic interactions are more complex.

We suspect that overall prevalence of NPSP may have been underestimated, as (i) the delay of onset of pain may be in a range between some days to several months, (ii) there is not always a systematic follow-up after most of the surgical procedures, and patients may stay out of the medical network and (iii) the benefit provided by the surgical procedure may lead to patient not to complain from a somewhat "necessary" complication.

No large epidemiologic study has been performed concerning neuropathic post-surgical pain at this date. The principal aim of this study is to know the exact prevalence of NPSP, 3 and 6 months after the date of surgery. Only nine surgical procedures have been considered for the study, according to the previous data of literature and/or the high frequency of practice. This is a prospective open epidemiologic study, performed in nine French university general hospitals, three anti-cancer university hospitals and many other general hospitals. The secondary endpoints are (i) to find a relationship (by multivariate analysis) between NPSP and a large number of clinical/biological items (quality of life, habits, treatments, drug abuse, psychic/mental state, genome?) collected preoperatively, (ii) to validate a self-completed version of a questionnaire already validated for discriminating the neuropathic feature of chronic pain (DN4), and (iii) to assess the availability of the existing medical networks for the care of NPSP.

Patients (age > 18) scheduled for one of the nine types of surgery will be recruited. The number of patients (following table) to be recruited has been calculated on the basis of the reported prevalence of pain in literature (set to 20% if no data were available), with a risk set to 5%, a precision measure set to 5% and a prediction of 20% of lost patients during the study.

Type of surgery Number requested Caesarean section 103 Inguinal hernia repair (under laparoscopy) 389 Inguinal hernia repair (without mesh) 389 Inguinal hernia repair (with mesh) 389 Mastectomy (simple without axillary node dissection) 454 Cholecystectomy (under laparoscopy) 297 Saphenectomy (excluding harvesting for coronary bypass) 167 Sternotomy 374 Thoracotomy 463 Knee arthroscopy 297 Total 3322

The anaesthetist in charge of the patient during the pre-anaesthetic visit will complete the data sheet concerning the preoperative status of the patient. He will proceed to the inclusion and provide the data concerning the anaesthetic and analgesic protocol that have been followed. The inclusion will be registered by the local coordinating assistant, who will (i) send to the patient self-questionnaires 3 and 6 months after the date of surgery (about pain, neuropathic symptoms and the resulting quality of life) and (ii) transfer the information to the national coordinating centre (Centre for Clinical Investigations of Clermont-Ferrand). A permanent monitoring of inclusions and follow-up will be performed at both local and national levels. This will help to organise the rhythm and the location of inclusions at any time of the study.

If a case of chronic pain is identified, the willing patient will be sent to the closest Centre for Evaluation and Treatment of Pain, in which the diagnosis will be completed and a treatment initiated if required. For the validation of the self-completed version of the DN4 questionnaire, data from painless, painful neuropathic, and painful non-neuropathic patients, will be compared.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Definied population
Condition Neuropathic Pain
Intervention Procedure: Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)
Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)
Study Groups/Cohorts surgery
Intervention: Procedure: Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 19, 2008)
3322
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Agreement to the study
  • Scheduled for one of the following surgeries :

    • caesarean section
    • inguinal hernia repair
    • mastectomy
    • cholecystectomy under laparoscopy
    • saphenectomy (excluding harvesting for coronary bypass)
    • sternotomy
    • thoracotomy
    • knee arthroscopy
  • Major over 18 years

Exclusion Criteria:

  • Emergency
  • Inability to fill questionnaires
  • Unreachable patients
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00812734
Other Study ID Numbers CHU-0044
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators Pfizer
Investigators
Principal Investigator:Christian DualéUniversity Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date April 2013