Pain, Postoperative Clinical Trial
Official title:
Evaluation of a Novel Web-based Application for Monitoring Postoperative Pain in Patients Underwent Total Ankle Replacement
NCT number | NCT03777072 |
Other study ID # | ARP1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 12, 2018 |
Est. completion date | December 30, 2020 |
The study evaluates a novel web-based application for monitoring the postoperative pain in patients undergoing total ankle replacement, from preoperative condition to 30 days follow-up. The indexes provided by the app in terms of percentages of pain areas are compared with that obtained with traditional visual analogue scale. Moreover, the relation between the percentage of pain area and the presence of side effects of the intervention are compared as well.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - age from 18 to 60 years - ankle arthrosis grade 3 or 4, according to Kellgren-Lawrence classification - subject undergoing first implant of total ankle replacement - skeletal maturity - signed informed consent Exclusion Criteria: - previous ankle replacement implants or ipsilateral ankle arthrodesis |
Country | Name | City | State |
---|---|---|---|
Italy | Irccs Istituto Ortopedico Galeazzi | Milan | Milano |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Galeazzi |
Italy,
Boudreau SA, Badsberg S, Christensen SW, Egsgaard LL. Digital Pain Drawings: Assessing Touch-Screen Technology and 3D Body Schemas. Clin J Pain. 2016 Feb;32(2):139-45. doi: 10.1097/AJP.0000000000000230. — View Citation
Campbell WI, Lewis S. Visual analogue measurement of pain. Ulster Med J. 1990 Oct;59(2):149-54. — View Citation
Haeseler G, Schaefers D, Prison N, Ahrens J, Liu X, Karch A. Combatting pain after orthopedic/trauma surgery- perioperative oral extended-release tapentadol vs. extended-release oxycodone/naloxone. BMC Anesthesiol. 2017 Jul 11;17(1):91. doi: 10.1186/s12871-017-0383-6. — View Citation
Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009 Feb;31(2):260-71. doi: 10.1016/j.clinthera.2009.02.009. — View Citation
Matthews M, Rathleff MS, Vicenzino B, Boudreau SA. Capturing patient-reported area of knee pain: a concurrent validity study using digital technology in patients with patellofemoral pain. PeerJ. 2018 Mar 8;6:e4406. doi: 10.7717/peerj.4406. eCollection 2018. — View Citation
Nett MP. Postoperative pain management. Orthopedics. 2010 Sep;33(9 Suppl):23-6. doi: 10.3928/01477447-20100722-60. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain area index | Quantifies the percentage of pain area with respect to the total body area in the considered plane | Through study completion, an average of 18 months | |
Primary | VAS score | Continuous value ranging from 0 (minimum) to 10 (maximum), indicating the pain level reported by patient. | Through study completion, an average of 18 months | |
Primary | Presence of side effects | Dichotomic variable. Equal to 1 in case of reported side effects, 0 otherwise. | Through study completion, an average of 18 months |
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