Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2022-10-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Radical Prostatectomies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Opioid Control Cohort

One treatment selected:

Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

Opioid Control Cohort (One treatment selected)

Hydrocodone-Acetaminophen

Intervention Type DRUG

Opioid Control Cohort (One treatment selected)

Oxycodone-Acetaminophen

Intervention Type DRUG

Opioid Control Cohort (One treatment selected)

Experimental Cohort

Multimodal Approach:

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

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Experimental Cohort (Multimodal Approach)

Ketorolac

Intervention Type DRUG

Experimental Cohort (Multimodal Approach)

Acetaminophen

Intervention Type DRUG

Experimental Cohort (Multimodal Approach)

Ketorolac tromethamine

Intervention Type DRUG

Experimental Cohort (Multimodal Approach)

Ketamine

Intervention Type DRUG

Experimental Cohort (Multimodal Approach)

Interventions

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Tramadol

Opioid Control Cohort (One treatment selected)

Intervention Type DRUG

Gabapentin

Experimental Cohort (Multimodal Approach)

Intervention Type DRUG

Hydrocodone-Acetaminophen

Opioid Control Cohort (One treatment selected)

Intervention Type DRUG

Oxycodone-Acetaminophen

Opioid Control Cohort (One treatment selected)

Intervention Type DRUG

Ketorolac

Experimental Cohort (Multimodal Approach)

Intervention Type DRUG

Acetaminophen

Experimental Cohort (Multimodal Approach)

Intervention Type DRUG

Ketorolac tromethamine

Experimental Cohort (Multimodal Approach)

Intervention Type DRUG

Ketamine

Experimental Cohort (Multimodal Approach)

Intervention Type DRUG

Other Intervention Names

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Opioid Opioid Opioid

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No