Pain, Postoperative Clinical Trial
— MMPITROfficial title:
Randomized Comparison of Two Pre-induction Analgesia Regimens: Multimodal vs Acetaminophen in the Reduction of Post-operative Pain Following Ureteroscopy With Lithotripsy for Kidney Stones Evaluated With Text Messaging
Verified date | December 2018 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Adult patients with kidney stones undergoing surgical intervention with ureteroscopy with laser lithotripsy will be randomized to receive one of two different regimens of oral medications administered prior to induction of general anesthesia. Postoperatively, patients will receive automated daily text messages to assess pain and opioid consumption and subsequently determine which which treatment regimen is superior.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Adult Patient (greater than 18 years old) - Possesses or has access to cell phone with text message capability - Undergoing ureteroscopy with lithotripsy for a ureteral or kidney stones Exclusion Criteria: - Does not possess or have access to a cell phone with text message capability - Non-English speaking - Incarcerated individuals - undergoing planned secondary procedure - pregnancy - intellectual disability - History of, anaphylactic, rash, or other hypersensitivity reaction to any of the study agents - Patients with history of CABG, myocardial infarction, endovascular cardiac stent, gastrointestinal bleed, or gastric ulcer disease will not receive Celecoxib. They may still participate in the study otherwise, it will be documented that they did not receive an NSAID component. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Kevin J Flynn MD |
Ahn ST, Kim JH, Park JY, Moon du G, Bae JH. Acute postoperative pain after ureteroscopic removal of stone: incidence and risk factors. Korean J Urol. 2012 Jan;53(1):34-9. doi: 10.4111/kju.2012.53.1.34. Epub 2012 Jan 25. — View Citation
Barnes KT, Bing MT, Tracy CR. Do ureteric stent extraction strings affect stent-related quality of life or complications after ureteroscopy for urolithiasis: a prospective randomised control trial. BJU Int. 2014 Apr;113(4):605-9. doi: 10.1111/bju.12541. — View Citation
Hirschtritt ME, Delucchi KL, Olfson M. Outpatient, combined use of opioid and benzodiazepine medications in the United States, 1993-2014. Prev Med Rep. 2017 Dec 21;9:49-54. doi: 10.1016/j.pmedr.2017.12.010. eCollection 2018 Mar. — View Citation
Oberlin DT, Flum AS, Bachrach L, Matulewicz RS, Flury SC. Contemporary surgical trends in the management of upper tract calculi. J Urol. 2015 Mar;193(3):880-4. doi: 10.1016/j.juro.2014.09.006. Epub 2014 Sep 16. — View Citation
Penprase B, Brunetto E, Dahmani E, Forthoffer JJ, Kapoor S. The efficacy of preemptive analgesia for postoperative pain control: a systematic review of the literature. AORN J. 2015 Jan;101(1):94-105.e8. doi: 10.1016/j.aorn.2014.01.030. Review. — View Citation
Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative day 0 Pain | The magnitude of pain (0-10) that the patient experiences in the evening after their surgery concludes | 4-6 hours after conclusion of surgery | |
Secondary | Time to pain resolution | The amount of time (days) that it takes for patients to report a pain level of less than 4 (0-10 scale) | Approximately the first 72-96 hours | |
Secondary | Opioid Consumption | The number of total opioid pills a patient consumes following surgery | 14 days following surgery | |
Secondary | Time to complete pain resolution | The amount of time (days) that it takes for patients to report a pain level of 0 (0-10 scale) | 14 days |
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