Pain Clinical Trial
Official title:
Optimizing Pain Control in Transurethral Resection of the Prostate
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Mason Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Benaroya Research Institute | Virginia Mason Hospital/Medical Center |
United States,
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
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 |
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