Optimizing Pain Control in Transurethral Resection of the Prostate

Pain Clinical Trial

Official title:

Optimizing Pain Control in Transurethral Resection of the Prostate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102566
• Other study ID #: IRB17-098
• Status: Recruiting
• Phase: Phase 4
• Start date: December 8, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: September 2019
• Source: Benaroya Research Institute
• Contact: Ryan Donahue, MD
• Phone: 2062236600
• Email: ryan.donahue[@]vmmc.org
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ibuprofen 600 mg
We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.

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

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Benaroya Research Institute	Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Köse O, Saglam HS, Altun ME, Sonbahar T, Kumsar S, Adsan Ö. 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. — View Citation

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. — View Citation

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. Erratum in: JAMA Intern Med. 2016 Sep 1;176(9):1412. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	Total opioid utilization	PACU-72 hours
Primary	Pain Scores	Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)	PACU-72 hours
Secondary	Presence of a foley catheter at discharge.	Was the patient discharged with a Foley catheter?	0-48hours
Secondary	Presence of narcotic side effects	nausea/vomiting, pruritus, constipation, dizziness or feelings of sedation	48 hours after discharge
Secondary	Were there any post-operative complications	Any complications post-operatively that occurred in the immediate post-operative setting.	0-48 hours