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

Chronic Postoperative Pain Clinical Trial

— SMS DPpostop  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04313855
• Other study ID #: SMS DPpostop
• Status: Completed
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: October 28, 2022

Study information

• Verified date: October 2022
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: October 28, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Neuralgia
• Pain, Postoperative

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (14)

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. 20 — View Citation

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 — View Citation

Carrier G, Cotte E, Beyer-Berjot L, Faucheron JL, Joris J, Slim K; Groupe Francophone de Réhabilitation Améliorée après Chirurgie (GRACE). Post-discharge follow-up using text messaging within an enhanced recovery program after colorectal surgery. J Visc S — View Citation

Chen Y, Chin M, Greenberg S, Johnstone C, McGuinness J. Post-tonsillectomy pain in 24 children - utilising short message service (SMS) to assess postoperative outcomes. Clin Otolaryngol. 2012 Oct;37(5):412-4. doi: 10.1111/j.1749-4486.2012.02521.x. — View Citation

Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An o — View Citation

Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6. Review. — View Citation

Hoofwijk DM, Fiddelers AA, Peters ML, Stessel B, Kessels AG, Joosten EA, Gramke HF, Marcus MA. Prevalence and Predictive Factors of Chronic Postsurgical Pain and Poor Global Recovery 1 Year After Outpatient Surgery. Clin J Pain. 2015 Dec;31(12):1017-25. d — View Citation

Hoofwijk DMN, Fiddelers AAA, Emans PJ, Joosten EA, Gramke HF, Marcus MAE, Buhre WFFA. Prevalence and Predictive Factors of Chronic Postsurgical Pain and Global Surgical Recovery 1 Year After Outpatient Knee Arthroscopy: A Prospective Cohort Study. Medicin — View Citation

Johansen A, Romundstad L, Nielsen CS, Schirmer H, Stubhaug A. Persistent postsurgical pain in a general population: prevalence and predictors in the Tromsø study. Pain. 2012 Jul;153(7):1390-1396. doi: 10.1016/j.pain.2012.02.018. Epub 2012 Mar 24. — View Citation

Lu K, Marino NE, Russell D, Singareddy A, Zhang D, Hardi A, Kaar S, Puri V. Use of Short Message Service and Smartphone Applications in the Management of Surgical Patients: A Systematic Review. Telemed J E Health. 2018 Jun;24(6):406-414. doi: 10.1089/tmj. — View Citation

Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22. Review. — View Citation

Remérand F, Godfroid HB, Brilhault J, Vourc'h R, Druon J, Laffon M, Fusciardi J. Chronic pain 1 year after foot surgery: Epidemiology and associated factors. Orthop Traumatol Surg Res. 2014 Nov;100(7):767-73. doi: 10.1016/j.otsr.2014.07.012. Epub 2014 Oct — View Citation

van Zaane B, Vergouwe Y, Donders AR, Moons KG. Comparison of approaches to estimate confidence intervals of post-test probabilities of diagnostic test results in a nested case-control study. BMC Med Res Methodol. 2012 Oct 31;12:166. doi: 10.1186/1471-2288 — View Citation

Wall PD, Sprowson AP, Parsons N, Parsons H, Achten J, Balasubramanian S, Costa ML; Perioperative Analgesia for Knee Arthroplasty Collaborators. Protocol for a single-centre randomised controlled trial of multimodal periarticular anaesthetic infiltration v — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 7
Secondary	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.	Day 90
Secondary	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.	Day 90
Secondary	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.	Day 90
Secondary	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.	Day90
Secondary	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.	Day90