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

Not Applicable

Completed

• Conditions: Chronic Postoperative Pain
• Interventions: Diagnostic Test: SMS in the early detection of postoperative neuropathic pain

• Registration Number: NCT04313855
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Study Start: 2020-12-09
• Primary Completion: 2022-07-07
• Status Verified: 2022-10
• Study Completion: 2022-10-28
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic post-operative pain	SMS in the early detection of postoperative neuropathic pain	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 Measures

Name	Time	Method
diagnostic method	Day 7	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

Name	Time	Method
Persistent post-surgical pain day 90	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	Day 90	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	Day 90	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	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	Day90	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.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France