Clinical trial NCT04102566: Optimizing Pain Control in Transurethral Resection of the Prostate
Official title: Optimizing Pain Control in Transurethral Resection of the Prostate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain
BPH With Urinary Obstruction
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Keywords: postoperative pain
Transurethral resection of the prostate
Multimodal pain control
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
First posted: 2019-09-25
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Opioid Consumption
timeFrame: PACU-72 hours
measure: Pain Scores
timeFrame: PACU-72 hours
Secondary outcomes:
measure: Presence of a foley catheter at discharge.
timeFrame: 0-48hours
measure: Presence of narcotic side effects
timeFrame: 48 hours after discharge
measure: Were there any post-operative complications
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
References:
citation: 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.
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.
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.
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.
citation: 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.
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. No abstract available.
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.
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.