Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months

Pain Clinical Trial

— ETADOL  

Official title:

Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326737
• Other study ID #: LOCAL/2020/PC-02
• Secondary ID: 2020-A03223-36
• Status: Recruiting
• Start date: February 23, 2021
• Est. completion date: May 23, 2024

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Joël L'Hermite, MD
• Phone: +33.(0)4.66.68.36.18
• Email: joel.lhermite[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place.

Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Many preoperative, intraoperative, and postoperative factors, related to the patient, the surgical procedure, or the anesthetic technique, have been incriminated as risk factors for chronic post-surgical pain. The severity of acute postoperative pain is recognized as one of the risk factors for the occurrence of chronic post-surgical pain on which we can hope to interact during the peri-operative period.

In this cohort study, we wish to define the typologies of postoperative pain trajectories observed from Day 0 to Day 7 and to estimate the proportion of patients with an abnormal resolution of pain in a model of organization such as that of our institution, in classic hospitalization and in ambulatory care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 23, 2024
• Est. primary completion date: February 23, 2024
• 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

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
• Surgical Procedures, Operative

Intervention

Other:
• 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 PCS questionnaire between on day -1 or +1.
• Telephone contact at 3 months
Patients will be contacted at 3 months post-surgery for pain questionnaires DN4 and EQ5D5L.

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. Epub 2005 Jan 26. — 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 change in pain level evaluated by verbal numerical pain (from 0 to 10) from day 0 (surgery) to day 7.	Day 7
Secondary	The DN4 questionnaire	The Douleur Neuropathique 4 (DN4) questionnaire was developed by the French Neuropathic Pain Group and is a simple and objective tool, with the ability to distinguish nociceptive from neuropathic pain	month 3
Secondary	The EuroQuol EQ5D5L questionnaire	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	month 3
Secondary	Since the surgery, do you have persistent pain? yes/no	Since the surgery, do you have persistent pain? yes/no	month 3
Secondary	Verbal numerical scale for pain (ranging from 0 to 10)	Verbal numerical scale for pain (ranging from 0 to 10)	month 3
Secondary	Have you had complications from your surgery? yes/no	Have you had complications from your surgery? yes/no	month 3
Secondary	Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.	day -1 or day +1
Secondary	Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day -1 or day +1
Secondary	Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 2
Secondary	Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 3
Secondary	Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 4
Secondary	Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 5
Secondary	Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 6
Secondary	Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 7