Clinical trial NCT05597878: Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy
Official title: Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pain Management
Opioid Use
Prostate Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Pain Scores
timeFrame: Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)
Secondary outcomes:
measure: Opioid Oral Morphine Milligram Equivalents (OMEQ)
timeFrame: At Day 0 (Prior to surgery) and between Day 7-10 (postoperatively)
measure: Demographics of Participants
timeFrame: Day 0 (prior to surgery) to Day 1 (expected hospital discharge)
measure: Preoperative Characteristics of Participants
timeFrame: Day 0 (prior to surgery) to Day 1 (expected hospital discharge)
measure: Opioid-Related Symptom Distress Scale (ORSDS)
timeFrame: Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
name: Ashok Hemal, MD
role: PRINCIPAL_INVESTIGATOR
References: