Kidney CalculiPhase 4MMPITRNCT03549611
Pre-induction Analgesia: Multimodel Regimen vs Aceteminophen for Post Ureteroscopy Pain
A Phase 4 study testing Multimodal Oral Drug Regimen and Acetaminophen in people with Kidney Calculi and Pain, Postoperative, run by Kevin J Flynn MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Calculi, Pain, Postoperative
- What is being tested?
- Multimodal Oral Drug Regimen and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Acetaminophen 975mg
- Gabapentin 800mg
- Oxycodone 10mg
- Celecoxib 400mg
Acetaminophen Only Analgesia Arm
- 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
- Tylenol 650 every 6 hours x 7 day
- Oxybutynin 5mg three times daily as needed for x 7 days
- Flomax 0.4mg daily x 7 days
- Oxycodone, 5mg as needed 15 pills
- 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
- Conditions
- Kidney Calculi, Pain, Postoperative
- Being tested
- Multimodal Oral Drug Regimen, Acetaminophen
- Keywords
- ureteroscopy, opioids, narcotics, text messaging, real time data acquisition, ecologic momentary assessments, pre-emptive analgesia, gabapentin, meloxicam, tamsulosin, kidney stones, lithotripsy, nephrolithiasis
- Medical subject headings
- Kidney Calculi, Pain, Postoperative, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Oral Drug RegimenDrug
Also called Gabapentin 800mg, Oxycodone 10mg, Acetaminophen 975mg, Celecoxib 400mg
Regimen of 4 pharmacologic agents that provides analgesia by acting on 4 different physiologic pain pathways
AcetaminophenDrug
Also called Tylenol
Acetaminophen 975mg
| Study group | Role | What they receive |
|---|---|---|
| Multimodel Drug Regimen | Experimental | 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 Receives: Drug: Multimodal Oral Drug Regimen |
| Acetaminophen Only | Active comparator | The patients randomized to this arm will receive oral acetaminophen only administered shortly before induction of general anesthesia
1. Tylenol, 975mg (3 tabs) Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative day 0 Pain
The magnitude of pain (0-10) that the patient experiences in the evening after their surgery concludes
Measured: 4-6 hours after conclusion of surgery
Secondary outcomes (3)
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)
Measured: Approximately the first 72-96 hours
Opioid Consumption
The number of total opioid pills a patient consumes following surgery
Measured: 14 days following surgery
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)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Aug 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Why it stopped: elected not to proceed with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin J Flynn MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kevin J Flynn MD, University of Iowa
- Investigators
- Chad Tracy, MD, Principal investigator, University of Iowa Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549611
- Sponsor's protocol ID
- 201805826
- Acronym
- MMPITR
- Status last verified
- Dec 2018
- First submitted
- 25 May 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Publications
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.
PubMed 22323972Penprase 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.
PubMed 25537330Scales 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.
PubMed 22498635Oberlin 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.
PubMed 25219700Barnes 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.
PubMed 24765679Hirschtritt 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.
PubMed 29340270
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03549611
- Acronym / sponsor ID
- MMPITR / 201805826
- Conditions
- Kidney Calculi, Pain, Postoperative
- Keywords
- ureteroscopy, opioids, narcotics, text messaging, real time data acquisition, ecologic momentary assessments, pre-emptive analgesia, gabapentin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: elected not to proceed with the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kevin J Flynn MDUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Acetaminophen 975mg
- Gabapentin 800mg
- Oxycodone 10mg
- Celecoxib 400mg
Acetaminophen Only Analgesia Arm
- 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
- Tylenol 650 every 6 hours x 7 day
- Oxybutynin 5mg three times daily as needed for x 7 days
- Flomax 0.4mg daily x 7 days
- Oxycodone, 5mg as needed 15 pills
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodel Drug Regimen | Experimental | Drug: Multimodal Oral Drug RegimenThe 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 |
| Acetaminophen Only | Active comparator | Drug: AcetaminophenThe patients randomized to this arm will receive oral acetaminophen only administered shortly before induction of general anesthesia 1. Tylenol, 975mg (3 tabs) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Does not possess or have access to a cell phone with text message capability
- Non-English speaking
- Incarcerated individuals
- undergoing planned secondary procedure
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Oral Drug RegimenAlso: Gabapentin 800mg, Oxycodone 10mg, Acetaminophen 975mg, Celecoxib 400mgRegimen of 4 pharmacologic agents that provides analgesia by acting on 4 different physiologic pain pathways | Drug | Multimodel Drug Regimen |
| AcetaminophenAlso: TylenolAcetaminophen 975mg | Drug | Acetaminophen Only |
Primary outcome
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
3 secondary outcomes
Time to pain resolution
Time frame: Approximately the first 72-96 hours
Opioid Consumption
Time frame: 14 days following surgery
Time to complete pain resolution
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Background: PubMed 22323972Ahn 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.
- Background: PubMed 25537330Penprase 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.
- Background: PubMed 22498635Scales 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.
- Background: PubMed 25219700Oberlin 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.
- Background: PubMed 24765679Barnes 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.
- Background: PubMed 29340270Hirschtritt 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.
- Individual participant dataSharing planned: No. Data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Tracy, MD principal investigator
University of Iowa Department of Urology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multimodal Oral Drug Regimen and Acetaminophen in people with Kidney Calculi and Pain, Postoperative, run by Kevin J Flynn MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative day 0 Pain (time frame: 4-6 hours after conclusion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549611, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.