Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03549611
Recruitment Status : Withdrawn (elected not to proceed with the study)
First Posted : June 8, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Kevin J Flynn MD, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Kidney Calculi Pain, Postoperative Drug: Multimodal Oral Drug Regimen Drug: Acetaminophen Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The patient will not be made aware which treatment regimen they are receiving and neither will the attending urologist.
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Experimental: Multimodel Drug Regimen

The patients randomized to this arm will receive the following multimodal oral drug regimen administered shortly before induction of general anesthesia

  1. Tylenol, 975mg (3 tabs)
  2. 800mg Gabapentin
  3. 400mg Celecoxib
  4. 10mg Oxycodone
Drug: Multimodal Oral Drug Regimen
Regimen of 4 pharmacologic agents that provides analgesia by acting on 4 different physiologic pain pathways
Other Names:
  • Gabapentin 800mg
  • Oxycodone 10mg
  • Acetaminophen 975mg
  • Celecoxib 400mg

Active Comparator: Acetaminophen Only

The patients randomized to this arm will receive oral acetaminophen only administered shortly before induction of general anesthesia

1. Tylenol, 975mg (3 tabs)

Drug: Acetaminophen
Acetaminophen 975mg
Other Name: Tylenol




Primary Outcome Measures :
  1. Postoperative day 0 Pain [ Time Frame: 4-6 hours after conclusion of surgery ]
    The magnitude of pain (0-10) that the patient experiences in the evening after their surgery concludes


Secondary Outcome Measures :
  1. Time to pain resolution [ Time Frame: Approximately the first 72-96 hours ]
    The amount of time (days) that it takes for patients to report a pain level of less than 4 (0-10 scale)

  2. Opioid Consumption [ Time Frame: 14 days following surgery ]
    The number of total opioid pills a patient consumes following surgery

  3. Time to complete pain resolution [ Time Frame: 14 days ]
    The amount of time (days) that it takes for patients to report a pain level of 0 (0-10 scale)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549611


Sponsors and Collaborators
Kevin J Flynn MD
Investigators
Layout table for investigator information
Principal Investigator: Chad Tracy, MD University of Iowa Department of Urology

Publications:
Layout table for additonal information
Responsible Party: Kevin J Flynn MD, Urology Resident, University of Iowa
ClinicalTrials.gov Identifier: NCT03549611     History of Changes
Other Study ID Numbers: 201805826
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Kevin J Flynn MD, University of Iowa:
ureteroscopy
opioids
narcotics
text messaging
real time data acquisition
ecologic momentary assessments
pre-emptive analgesia
gabapentin
meloxicam
tamsulosin
kidney stones
lithotripsy
nephrolithiasis

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Calculi
Nephrolithiasis
Pain, Postoperative
Calculi
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Acetaminophen
Celecoxib
Oxycodone
Gabapentin
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors