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Help With Early Detection of Postoperative Neuropathic Pain Using SMS After Ambulatory Surgery (SMS DPpostop)

Primary Purpose

Chronic Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SMS in the early detection of postoperative neuropathic pain
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient aged ≥ 18 years
  • Patient hospitalized on an outpatient basis within the Paris Saint Joseph Hospital Group in the following different surgical specialties: orthopedics, digestive, vascular, gynecological, plastic and restorative
  • French speaking patient
  • Patient with smartphone
  • Patient affiliated to a social security scheme
  • Patient having given oral, free, informed and express consent

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty

Sites / Locations

  • Groupe Hospitalier Paris Saint-Joseph

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic post-operative pain

Arm Description

7 days after the intervention, the patient receives a standardized questionnaire by SMS, to determine whether the patient has pain at the operating site and whether this pain has the characteristics of neuropathic pain. After replying to the SMS, the patient will be contacted by phone to assess: the intensity of pain at the operating site using a numerical scale and the existence of neuropathic pain. Depending on the responses received by SMS and/or phone, a consultation appointment with an anesthesiologist specializing in pain may be offered within a maximum of 2 weeks. Ninety days after your surgery, the patient receives the same standardized questionnaire by SMS. The patient will be contacted by telephone, in order to assess the intensity of pain at the operating site and the existence of neuropathic pain using. If the patient has post-operative pain, a consultation appointment with an anesthesiologist specializing in pain will be offered to him within a maximum of 2 weeks.

Outcomes

Primary Outcome Measures

diagnostic method
This outcome corresponds to the calculation of the sensitivity and the specificity of the diagnostic method tested which is the combination of SMS and the DN2 questionnaire.

Secondary Outcome Measures

Persistent post-surgical pain day 90
This oucome correspond to corresponds to the proportion of patients with persistent post-surgical pain at seven days after surgery performed on an outpatient basis.
Neuropathic pain day90
This outcome correspond to the proportion of neuropathic pain on Day90 estimated using the questionnaires DN4 and NPSI during the postoperative pain consultation.
signs suggestive of neuropathic pain day90
This outcome correspond to the proportion of patients with signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain 90 days after the intervention.
Comparison of pain between day7 and day90
This outcome corresponds to the comparison of the proportion of patients with signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain between Day7 and Day90 after the intervention.
Proportion of patients presenting signs suggestive of pain
This ouctome corresponds to the proportion of patients presenting signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain on Day90 who had presented pain on Day7.

Full Information

First Posted
March 16, 2020
Last Updated
October 31, 2022
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT04313855
Brief Title
Help With Early Detection of Postoperative Neuropathic Pain Using SMS After Ambulatory Surgery
Acronym
SMS DPpostop
Official Title
Help With Early Detection of Postoperative Neuropathic Pain Using SMS After Ambulatory Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic post-operative pain is generally defined by persistent pain more than 2 months after surgery. General reviews on chronic post-operative pain describe an overall incidence of 30%, of which 5 to 10% are described as severe. Different risk factors have been identified: pain and preoperative opioid use, anxiety - depression, catastrophism, type of surgery, intensity and duration of postoperative pain, genetic factors. If postoperative pain is essentially pain caused by excess nociceptive stimulation, investigators realize that a neuropathic component is far from being exceptional and that this can be demonstrated quickly after surgery. In addition, these neuropathic pains respond little or no to the usual analgesics and in particular to opioids, which can be the cause of misuse or death from overdose. Early detection of pain of a neuropathic nature would allow appropriate therapy to be put in place and may therefore reduce the risk of chronic postoperative pain. The concept of ambulatory surgery assumes that postoperative pain will be minimal and can be controlled at home by the administration of oral pain relievers. However, following the development of surgical techniques and the improvement in the quality of care, the number and complexity of procedures that can be performed in ambulatory surgery have increased considerably. Consequently, a significant number of patients will probably develop chronic post-operative pain without the possibility of early detection. The prevalence of chronic post-operative pain in ambulatory surgery has been studied by a single team. The authors conclude that it is underestimated and variable depending on the surgery between 15 and 32%. For the past few years, the GHPSJ has been using an ambulatory surgery algorithm that sends SMS messages to warn and follow up on patients. The principle is simple: patients scheduled for outpatient surgery receive text messages the day before their intervention to remind them of the instructions to be followed and the meeting times and, the day after the operation, the algorithm sends SMS to ask patients if all is well or if they have pain, nausea or vomiting, discharge from the scar. In postoperative monitoring, this technology has shown promising results. This technology has not been used in the screening of persistent pain. The objective of this work is to assess the effectiveness of an SMS algorithm in the early detection of postoperative neuropathic pain after surgery performed on an outpatient basis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Postoperative Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective case-control diagnostic study nestled in a cohort. The cohort is the set of patients operated on ambulatory surgery on the GHPSJ. In this cohort, pain patients according to the doctor's opinion are the cases. The controls are the patients who are not painful according to the doctor's opinion. For reasons of available consultation time slots, it is not possible to see all of the patients. It was therefore decided to see all the painful patients and to select by lot the painless patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic post-operative pain
Arm Type
Experimental
Arm Description
7 days after the intervention, the patient receives a standardized questionnaire by SMS, to determine whether the patient has pain at the operating site and whether this pain has the characteristics of neuropathic pain. After replying to the SMS, the patient will be contacted by phone to assess: the intensity of pain at the operating site using a numerical scale and the existence of neuropathic pain. Depending on the responses received by SMS and/or phone, a consultation appointment with an anesthesiologist specializing in pain may be offered within a maximum of 2 weeks. Ninety days after your surgery, the patient receives the same standardized questionnaire by SMS. The patient will be contacted by telephone, in order to assess the intensity of pain at the operating site and the existence of neuropathic pain using. If the patient has post-operative pain, a consultation appointment with an anesthesiologist specializing in pain will be offered to him within a maximum of 2 weeks.
Intervention Type
Diagnostic Test
Intervention Name(s)
SMS in the early detection of postoperative neuropathic pain
Intervention Description
7 days after the intervention, the patient receives a standardized questionnaire by SMS, to determine whether the patient has pain at the operating site and whether this pain has the characteristics of neuropathic pain. After replying to the SMS, the patient will be contacted by phone to assess: the intensity of pain at the operating site using a numerical scale and the existence of neuropathic pain. Depending on the responses received by SMS and/or phone, a consultation appointment with an anesthesiologist specializing in pain may be offered within a maximum of 2 weeks. Ninety days after your surgery, the patient receives the same standardized questionnaire by SMS. The patient will be contacted by telephone, in order to assess the intensity of pain at the operating site and the existence of neuropathic pain using. If the patient has post-operative pain, a consultation appointment with an anesthesiologist specializing in pain will be offered to him within a maximum of 2 weeks.
Primary Outcome Measure Information:
Title
diagnostic method
Description
This outcome corresponds to the calculation of the sensitivity and the specificity of the diagnostic method tested which is the combination of SMS and the DN2 questionnaire.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Persistent post-surgical pain day 90
Description
This oucome correspond to corresponds to the proportion of patients with persistent post-surgical pain at seven days after surgery performed on an outpatient basis.
Time Frame
Day 90
Title
Neuropathic pain day90
Description
This outcome correspond to the proportion of neuropathic pain on Day90 estimated using the questionnaires DN4 and NPSI during the postoperative pain consultation.
Time Frame
Day 90
Title
signs suggestive of neuropathic pain day90
Description
This outcome correspond to the proportion of patients with signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain 90 days after the intervention.
Time Frame
Day 90
Title
Comparison of pain between day7 and day90
Description
This outcome corresponds to the comparison of the proportion of patients with signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain between Day7 and Day90 after the intervention.
Time Frame
Day90
Title
Proportion of patients presenting signs suggestive of pain
Description
This ouctome corresponds to the proportion of patients presenting signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain on Day90 who had presented pain on Day7.
Time Frame
Day90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged ≥ 18 years Patient hospitalized on an outpatient basis within the Paris Saint Joseph Hospital Group in the following different surgical specialties: orthopedics, digestive, vascular, gynecological, plastic and restorative French speaking patient Patient with smartphone Patient affiliated to a social security scheme Patient having given oral, free, informed and express consent Exclusion Criteria: Patient under guardianship or curatorship Patient deprived of liberty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic ADAM, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18434337
Citation
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Results Reference
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PubMed Identifier
30983589
Citation
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Citation
Beloeil H, Sion B, Rousseau C, Albaladejo P, Raux M, Aubrun F, Martinez V; SFAR research network. Early postoperative neuropathic pain assessed by the DN4 score predicts an increased risk of persistent postsurgical neuropathic pain. Eur J Anaesthesiol. 2017 Oct;34(10):652-657. doi: 10.1097/EJA.0000000000000634.
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Citation
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Help With Early Detection of Postoperative Neuropathic Pain Using SMS After Ambulatory Surgery

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