Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

Wake Forest University (WFU)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Radical Prostatectomies

Treatments: Drug: Gabapentin; Drug: Acetaminophen; Drug: Oxycodone-Acetaminophen; Drug: Ketorolac; Drug: Tramadol; Drug: Ketorolac tromethamine; Drug: Ketamine; Drug: Hydrocodone-Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04939987

IRB00074034

Details and patient eligibility

About

This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.

Full description

This study will conduct a randomized control double-blind clinical trial to evaluate an opioid versus a non-opioid pathway of gabapentin, ketorolac, and acetaminophen in treating postoperative pain following robot-assisted radical prostatectomy (RARP).

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All men ages 40-75 undergoing bilateral robot assisted radical prostatectomy (RARP) with bilateral lymph node dissection with low-intermediate to high-risk localized prostate cancer

Exclusion criteria

• Allergies to any medication involved in the study
• T4 prostate cancer
• incarcerated persons
• chronic narcotic dependence
• any current prescription for narcotics
• any surgery in the past 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Opioid Control Cohort

Active Comparator group

Description:

One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)

Treatment:

Drug: Hydrocodone-Acetaminophen

Drug: Tramadol

Drug: Oxycodone-Acetaminophen

Experimental Cohort

Experimental group

Description:

Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)

Treatment:

Drug: Ketorolac tromethamine

Drug: Gabapentin

Drug: Acetaminophen

Drug: Ketamine

Drug: Ketorolac