Optimizing Pain Control in Transurethral Resection of the Prostate

NCT ID: NCT04102566

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-08
• Study Completion Date: 2019-12-01

Brief 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. The investigators believe this is an important step in reducing the opioid epidemic in surgical patients.

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.

Conditions

Pain; BPH With Urinary Obstruction; BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care arm

The 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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multi-modal group

The 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

Group Type: EXPERIMENTAL

Ibuprofen 600 mg

Intervention Type: DRUG

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

Education

Intervention Type: BEHAVIORAL

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

Interventions

Ibuprofen 600 mg

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

Intervention Type: DRUG

Education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Mason Hospital/Medical Center

OTHER

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Una Lee

Principal Investigator and Attending urologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan Donahue, MD

Role: CONTACT

ryan.donahue@vmmc.org

2062236600

Facility Contacts

Ryan Donahue, MD

Role: primary

ryan.donahue@vmmc.org

512-484-3214

Una Lee, MD

Role: backup

una.lee@vmmc.org

2062236749

References

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.

Reference Type: BACKGROUND

PMID: 22412106 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27400458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28267689 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27631771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23565930 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22227789 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26977696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27663358 (View on PubMed)

Other Identifiers

IRB17-098

Identifier Type: -

Identifier Source: org_study_id