About this trial
This prospective, interventional, open-label, phase 3 randomized study evaluates a multimodal analgesia discharge pathway to reduce automatic opioid prescribing following routine robotic-assisted laparoscopic prostatectomy (RALP). Patients are counseled on post-operative pain management and then may opt into or out of the study with randomization to discharge prescriptions including (A) multimodal plan with additional automatic opioid prescription or (B) multimodal plan alone and instruction to call phone line to request opioid prescription if pain management is insufficient. Additionally, a cohort of historical controls prior to implementation of the study is also prospectively assessed as a pre-study baseline. The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including emergency department visits or postoperative phone calls, and same-day discharge rates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men ≥45 years old
Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
Able to provide informed consent
Disqualifiers
Chronic kidney disease (baseline Cr >1.3)
NSAID contraindication/allergy
Regular opioid use or substance abuse prior to surgery
Inability to provide their own consent
Trial design
Parallel
Treatments tested in this trial
multimodal analgesia pathway with up-front small opioid prescription
Drugmultimodal analgesia pathway including an up-front small opioid prescription
multimodal analgesia pathway without up-front small opioid prescription
Drugmultimodal analgesia pathway without up-front small opioid prescription
pre-implementation baseline including opioid
Drugpre-implementation baseline including opioid
Treatment groups
Trial outcomes
Primary outcomes
Post-discharge opioid consumption (MME)
assessed at post-operative visit
Secondary outcomes
Return of bowel function
Emergency Department visits
Postoperative phone calls
Same-day discharge rate
Index hospitalization
Sponsors and contacts
Click on the lead sponsor to view all of their trials.