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Pre-induction Analgesia: Multimodel Regimen vs Aceteminophen for Post Ureteroscopy Pain

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03549611
Acronym
MMPITR
Enrollment
0
Registered
2018-06-08
Start date
2018-08-01
Completion date
2019-06-30
Last updated
2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

DRUGMultimodal Oral Drug Regimen

Regimen of 4 pharmacologic agents that provides analgesia by acting on 4 different physiologic pain pathways

DRUGAcetaminophen

Acetaminophen 975mg

Sponsors

Kevin J Flynn MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The patient will not be made aware which treatment regimen they are receiving and neither will the attending urologist.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative day 0 Pain4-6 hours after conclusion of surgeryThe magnitude of pain (0-10) that the patient experiences in the evening after their surgery concludes

Secondary

MeasureTime frameDescription
Time to pain resolutionApproximately the first 72-96 hoursThe amount of time (days) that it takes for patients to report a pain level of less than 4 (0-10 scale)
Opioid Consumption14 days following surgeryThe number of total opioid pills a patient consumes following surgery
Time to complete pain resolution14 daysThe amount of time (days) that it takes for patients to report a pain level of 0 (0-10 scale)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026