Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity

Pain Clinical Trial

— PATCH  

Official title:

Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599233
• Other study ID #: LOCAL/2015/JLH-01
• Secondary ID: 2015-A00868-41
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: January 31, 2017
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.

Description:

The secondary objectives of this study are:

A. To assess the incidence of Post-Surgical Chronic Pain (PSCP) Chronic 3 months post intervention.

B. To asses the incidence of neuropathic type pain (DN4 Questionnaire) at 3 months post intervention.

C. To study the potential links between pain trajectories and the presence or absence of PSCP.

D. To study the potential links between the presence or absence of PSCP and known risk factors for PSCP (patient-related data, data on the surgery, anesthesia data).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must be insured or beneficiary of a health insurance plan

• The patient is available for 3 months of follow-up

• The patient has undergone a planned surgical procedure in one of the participating departments

• The patient is willing and able to respond to the study questionnaires (HADS, PCS, EN, DN4)

Exclusion Criteria:

• The patient is participating in another study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, under tutorship or curatorship

• It is impossible to correctly inform the patient

• Patient admitted to the ICU and still intubated at day 1

Related Conditions & MeSH terms

• Chronic Pain
• Pain
• Pain, Postoperative
• Surgical Procedures, Operative

Intervention

Other:
• Telephone conctact at 3 months
Patients will be contacted at 3 months post-surgery for pain questionnaires.
• In hospital pain evaluation
Patients will evaluate their pain levels via a verbal numerical scale on days 1(or-1), 2, 3, 4, 5, 6 & 7.
• In hospital questionnaires
Patients are required to fill out the HADS and PCS questionnaires between on day -1 or +1.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (2)

Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. — View Citation

Sullivan, M. J., Bishop, S. R., & Pivik, J. The pain catastrophizing scale: development and validation. Psychological assessment, 1995, 7(4), 524.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pain trajectory for the first 7 post-operative days.	The pain trajectory is the vector of 7 verbal numerical pain estimates (from 0 to 10) taken over 7 days (days 1 (or -1), 2, 3, 4, 5, 6 & 7).; Day 0 is the day of surgery.	Day 7 post-surgery
Secondary	The DN4 questionnaire		month 3
Secondary	Since the surgery, do you have persistent pain? yes/no		month 3
Secondary	Is it the same pain before the surgery? yes/no		month 3
Secondary	Verbal numberical scale for pain (ranging from 0 to 10)		month 3
Secondary	Have you had complications from your surgery? yes/no		month 3
Secondary	Hospital Anxiety and Depression Scale (HADS)		day -1 or day +1
Secondary	Pain Catastrophizing Scale (PCS)		day -1 or day +1
Secondary	Cumulative consumption of antalgic drugs		day -1 or day +1
Secondary	Cumulative consumption of antalgic drugs		day 2
Secondary	Cumulative consumption of antalgic drugs		day 3
Secondary	Cumulative consumption of antalgic drugs		day 4
Secondary	Cumulative consumption of antalgic drugs		day 5
Secondary	Cumulative consumption of antalgic drugs		day 6
Secondary	Cumulative consumption of antalgic drugs		day 7