Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Oxycodone
- Conditions
- Pain Management
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Pain Scores
- Status
- Suspended
- Last Updated
- last month
Overview
Brief Summary
The objective of this study is to conduct a randomized clinical trial to evaluate an opioid versus an opioid-free pathway of perioperative use of ketamine, ketorolac, and IV acetaminophen followed by the postoperative use of ketorolac, and oral acetaminophen for pain associated with robotic-assisted radical prostatectomy. Escalation to use of opioid treatment for the opioid-free constituents will be available if needed.
Detailed Description
Primary Objective(s): Compare the effectiveness of opioid and opioid-free pathways in treating post-surgical pain following robotic-assisted radical prostatectomy. Secondary Objective(s) * To determine the opioid usage in the opioid and non-opioid group from the start of the pain treatment administration until discharge in patients following robotic-assisted radical prostatectomy. * Determine and analyze preoperative and perioperative measures for opioid and non-opioid groups in patients following robotic-assisted radical prostatectomy. * Examine and evaluate adverse effects of opioid and opioid-free pathways in patients following robotic-assisted radical prostatectomy using a standardized scale for common post-operative adverse effects including bodily functions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All men ages 40-75 undergoing robot assisted radical prostatectomy (RARP) with or without bilateral lymph node dissection with low, intermediate, or high-risk prostate cancer.
- •Patients must have normal organ function as defined below:
- •AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
- •Creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Exclusion Criteria
- •Participants with known allergies to any medication involved in the study or its excipients,
- •Participants who are incarcerated persons,
- •Participants with a chronic narcotic dependence,
- •Participants with any prescription for narcotics in the past 30 days,
- •Participants who have had only major pelvic or abdominal surgeries as bowel, rectal colon, bladder, liver, gallbladder, kidney, etc. in the past 6 months.
- •Patients may not be receiving any other investigational agents.
- •Patients with known metastatic disease or brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Arms & Interventions
Opioid Control Cohort
Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. AFTER surgery participants will be administered oxycodone and acetaminophen.
Intervention: Oxycodone
Opioid Control Cohort
Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. AFTER surgery participants will be administered oxycodone and acetaminophen.
Intervention: Acetaminophen
Experimental Non-Opioid Cohort
Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. BEFORE and AFTER surgery participants will be administered Ketamine; DURING surgery Ketorolac and acetaminophen.
Intervention: Ketamine
Experimental Non-Opioid Cohort
Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. BEFORE and AFTER surgery participants will be administered Ketamine; DURING surgery Ketorolac and acetaminophen.
Intervention: Ketorolac
Experimental Non-Opioid Cohort
Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. BEFORE and AFTER surgery participants will be administered Ketamine; DURING surgery Ketorolac and acetaminophen.
Intervention: Acetaminophen
Outcomes
Primary Outcomes
Change in Pain Scores
Time Frame: Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)
Mean pain scores for opioid and opioid-free groups on Day 0, Day 1, and follow-up appointment between Day 7-10 will be summarized using means and standard deviations. To test that the Day 1 pain levels are not significantly worse in the opioid-free group than in the opioid group, a two sample one sided t-test with a null value of 1.5 for the difference between groups (the non-inferiority margin) will be used. The change in pain from day 0 to days 1, and 7-10 will be compared both within and between groups using t-tests. In addition, a repeated measures linear model, with pain as the outcome and selected demographics and group as covariates, will be used to assess the pain levels and changes in pain across time at all post-operative time points and between groups. Additional preoperative and perioperative covariates will be considered for the model.
Secondary Outcomes
- Preoperative Characteristics of Participants(Day 0 (prior to surgery) to Day 1 (expected hospital discharge))
- Opioid Oral Morphine Milligram Equivalents (OMEQ)(At Day 0 (Prior to surgery) and between Day 7-10 (postoperatively))
- Demographics of Participants(Day 0 (prior to surgery) to Day 1 (expected hospital discharge))
- Opioid-Related Symptom Distress Scale (ORSDS)(Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment))