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PainPhase 4NCT04102566

Optimizing Pain Control in Transurethral Resection of the Prostate

A Phase 4 study testing Ibuprofen 600 mg and Education in people with Pain and BPH With Urinary Obstruction, run by Benaroya Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to develop a multi-modal protocol for pain management after TURP that minimizes opioid use. The investigators hypothesize this approach will provide non-inferior pain control to the current standard of care which includes opioids as the primary agent. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
What is being tested?
Ibuprofen 600 mg and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
8 Dec 2017to 1 Dec 2019
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Are identified as candidates for TURP
  • Are 18 years of age or greater
  • Are proficient in English

Who cannot join

  • Have filled an opioid prescription in the last 2 months
  • Have an allergy to a medication included in the protocol
  • Have a history of pelvic radiation
  • Have renal failure (Serum Cr > 2.0 mg/dl), peptic ulcer disease, history of gastric bypass, cirrhosis, or other contraindication precluding use of NSAID's
  • Have liver failure, hepatitis, or alcohol abuse which precludes use of acetaminophen

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ryan Donahue, MD contact

2062236600

ryan.donahue@vmmc.org

United States1 site, 1 recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Ryan Donahue, MD, 512-484-3214, ryan.donahue@vmmc.org

    Una Lee, MD, 2062236749, una.lee@vmmc.org

    Recruiting

Other trials in United States

About this study

The purpose of this study is to develop a multi-modal protocol for pain management after TURP that minimizes opioid use. The investigators hypothesize this approach will provide non-inferior pain control to the current standard of care which includes opioids as the primary agent. The investigators believe this is an important step in reducing the opioid epidemic in surgical patients.

Read the detailed description

In our study, the investigators will randomize TURP patients to standard of care versus a multi-modal protocol. Multi-modal pain control is defined as: "analgesia that combines 2 or more agents that act by different mechanisms to provide analgesia with better pain relief and less opioids". In addition, patients in the intervention arm will receive education regarding pain control and opioid use. The investigators aim to demonstrate non-inferior pain control with this approach. The investigators hope this will inform new guidelines for pain control after TURP, minimize opioid use in this patient population, and educate physicians and patients on providing excellent pain control while minimizing the risks of opioid use. The investigators believe this could ultimately serve as a model for other endoscopic urologic procedures as well.

Being tested
Ibuprofen 600 mg, Education
Keywords
postoperative pain, Transurethral resection of the prostate, Multimodal pain control
Medical subject headings
Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibuprofen 600 mgDrug

    We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.

  • EducationBehavioural

    We'll be adding education to patient's post-operative instructions to aid in their pain control management.

Study groups in NCT04102566
Study groupRoleWhat they receive
Standard of care armNo interventionThe standard of care group will group will receive the following regimen while inpatient: * 2% topical lidocaine gel applied to catheter tip as needed for pain, maximum dose of 600mg in 12 hours * Acetaminophen 1000mg every 8 hours standing * Oxycodone 5mg PO every 4 hours as needed pain * Phenazopyridine 100mg TID as needed for urinary burning * Senna 1 tab every 12 hours * Miralax 17g powder once daily as needed for constipation The standard of care group will get the following prescriptions on discharge: * Oxycodone 5mg every 4 hours as needed pain - 15 tabs * Acetaminophen 1000mg every 8 hours standing for two days then as needed * Phenazopyridine 100mg TID as needed for urinary burning - 9 tabs * Senna 1 tab every 12 hours - 10 tabs
Multi-modal groupExperimentalThe multi-modal group will receive the following regimen while inpatient: * 2% topical lidocaine gel applied to catheter tip as needed for pain, maximum dose of 600mg in 12 hours * Acetaminophen 1000mg every 8 hours standing * Ibuprofen 600mg every 6 hours standing * Oxycodone 5mg PO every 4 hours as needed pain * Phenazopyridine 100mg TID as needed for urinary burning * Senna 1 tab every 12 hours * Miralax 17g powder once daily as needed for constipation * Patient Education (Figures 2 \& 3) The multi-modal group will receive the following prescriptions on discharge: * Acetaminophen 1000mg every 8 hours standing for two days then as needed - 30 tabs * Ibuprofen 600mg every 8 hours standing for two days then as needed - 30 tabs * Phenazopyridine 100mg TID as needed for urinary burning - 9 tabs * Senna 1 tab every 12 hours - 10 tabs
Receives: Drug: Ibuprofen 600 mg; Behavioral: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Consumption

    Total opioid utilization

    Measured: PACU-72 hours

  2. Pain Scores

    Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)

    Measured: PACU-72 hours

Secondary outcomes (3)

  1. Presence of a foley catheter at discharge.

    Was the patient discharged with a Foley catheter?

    Measured: 0-48hours

  2. Presence of narcotic side effects

    nausea/vomiting, pruritus, constipation, dizziness or feelings of sedation

    Measured: 48 hours after discharge

  3. Were there any post-operative complications

    Any complications post-operatively that occurred in the immediate post-operative setting.

    Measured: 0-48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start8 Dec 2017
  3. Primary completion1 Oct 2019 (estimated)
  4. Study completion1 Dec 2019 (estimated)

Resources

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
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04102566
Sponsor's protocol ID
IRB17-098
Status last verified
Sep 2019
First submitted
23 Sep 2019
Last updated
27 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared with other researchers. IPD will be used solely for this study cohort and protocol.

Publications

  • Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.

    PubMed 22412106

  • Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.

    PubMed 27400458

  • Hill MV, Stucke RS, McMahon ML, Beeman JL, Barth RJ Jr. An Educational Intervention Decreases Opioid Prescribing After General Surgical Operations. Ann Surg. 2018 Mar;267(3):468-472. doi: 10.1097/SLA.0000000000002198.

    PubMed 28267689

  • Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.

    PubMed 27631771

  • Kose O, Saglam HS, Altun ME, Sonbahar T, Kumsar S, Adsan O. Prilocaine irrigation for pain relief after transurethral resection of the prostate. J Endourol. 2013 Jul;27(7):892-5. doi: 10.1089/end.2013.0001. Epub 2013 Jun 12.

    PubMed 23565930

  • American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

    PubMed 22227789

  • Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.

    PubMed 26977696

  • Maughan BC, Hersh EV, Shofer FS, Wanner KJ, Archer E, Carrasco LR, Rhodes KV. Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial. Drug Alcohol Depend. 2016 Nov 1;168:328-334. doi: 10.1016/j.drugalcdep.2016.08.016. Epub 2016 Sep 20.

    PubMed 27663358

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibuprofen 600 mg and Education in people with Pain and BPH With Urinary Obstruction, run by Benaroya Research Institute at 1 site in United States.

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 5 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: looking for participants now, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ryan Donahue, MD (2062236600, ryan.donahue@vmmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Consumption (time frame: PACU-72 hours). The study lists 2 primary outcomes in all. 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 NCT04102566, which also lists 8 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 27 Sep 2019.

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