Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
United States
North Carolina
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
RECRUITING
Winston-salem
Contact Information
Primary
Study Coordinator
dwashing@wakehealth.edu
336-713-6627
Time Frame
Start Date: 2023-04-18
Estimated Completion Date: 2026-03
Participants
Target number of participants: 100
Treatments
Active_comparator: 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.
Active_comparator: 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.
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov