Clinical trial NCT03549611: Pre-induction Analgesia: Multimodel Regimen vs Aceteminophen for Post Ureteroscopy Pain
Official 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Kidney Calculi
Pain, Postoperative
Keywords: ureteroscopy
opioids
narcotics
text messaging
real time data acquisition
ecologic momentary assessments
pre-emptive analgesia
gabapentin
meloxicam
tamsulosin
kidney stones
lithotripsy
nephrolithiasis
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Adult patients undergoing ureteroscopy for kidney stones will be screened and those who meet initial study criteria (adult, English speaking, non-pregnant, non-intellectually disabled patients), will be sent an information letter outlining the study. Interested patients, who possess a phone capable of text messaging will be consented to enroll in the study and randomized to one of two preoperative analgesic treatment arms (see below) that will be administered in the preoperative area prior to induction of general anesthesia.

Multimodal Analgesia Arm

1. Acetaminophen 975mg
2. Gabapentin 800mg
3. Oxycodone 10mg
4. Celecoxib 400mg

Acetaminophen Only Analgesia Arm

a. Acetaminophen 975mg

Consenting patients will fill out a baseline demographics questionnaire as well as provide baseline levels of pain and opioid consumption prior to surgery. They will also be enrolled to receive automated postoperative pain assessments and opioid consumption inquiries via text message. The patients will be blinded to the treatment they are receiving. The research team will not be blinded. The patient will then proceed with their planned ureteroscopy. The patient will then undergo their planned ureteroscopy with lithotripsy for kidney stone disease; the study does not change any parameters about the surgery itself. The general anesthesia regimen will be standardized to one particular standard of care method so as to minimize the potential effect of confounders.

All patients (patients in both preoperative analgesia treatment regimen arms) will be monitored in the post-anesthesia recovery unit for pain, blood pressure, sedation level monitored by the Ramsey Sedation Scale. Once they have recovered appropriately and met standard discharge criteria they will be discharged with the following analgesic regimen

1. Tylenol 650 every 6 hours x 7 day
2. Oxybutynin 5mg three times daily as needed for x 7 days
3. Flomax 0.4mg daily x 7 days
4. Oxycodone, 5mg as needed 15 pills
5. Celecoxib daily for 7 days

Patients will receive a pain assessment via text message the evening of postoperative day 0, and then twice a day for 14 days. Patients will also receive an opioid consumption inquiry once a day for 14 days. On postoperative day 15 patients will be asked if they were happy with their postoperative pain control.

During the study period the research team will access the patients electronic medical record to review and record the following information

* Current medications
* height, weight, age, gender, marital status, city, state of residence
* Co-morbid medical conditions
* insurance
* stone parameters: size (mmm), location, laterality, number of stones,
* Operative factors: instruments used, operative time, operative complications
* post-operative course: emergency department visits, unexpected phone calls, unexpected clinic visits, other 30-day complications

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative day 0 Pain
timeFrame: 4-6 hours after conclusion of surgery
Secondary outcomes:
measure: Time to pain resolution
timeFrame: Approximately the first 72-96 hours
measure: Opioid Consumption
timeFrame: 14 days following surgery
measure: Time to complete pain resolution
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa Department of Urology
name: Chad Tracy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.