Radical ProstatectomiesPhase 2/3NCT04939987
Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy
A Phase 2/3 study testing Tramadol, Gabapentin and Hydrocodone-Acetaminophen in people with Radical Prostatectomies, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Radical Prostatectomies
- What is being tested?
- Tramadol, Gabapentin and Hydrocodone-Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2022to Oct 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.
Read the detailed 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).
- Conditions
- Radical Prostatectomies
- Being tested
- Tramadol, Gabapentin, Hydrocodone-Acetaminophen, Oxycodone-Acetaminophen, Ketorolac
- Keywords
- opioids, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Also called Opioid
Opioid Control Cohort (One treatment selected)
GabapentinDrug
Experimental Cohort (Multimodal Approach)
Hydrocodone-AcetaminophenDrug
Also called Opioid
Opioid Control Cohort (One treatment selected)
Oxycodone-AcetaminophenDrug
Also called Opioid
Opioid Control Cohort (One treatment selected)
KetorolacDrug
Experimental Cohort (Multimodal Approach)
AcetaminophenDrug
Experimental Cohort (Multimodal Approach)
Ketorolac tromethamineDrug
Experimental Cohort (Multimodal Approach)
KetamineDrug
Experimental Cohort (Multimodal Approach)
| Study group | Role | What they receive |
|---|---|---|
| Opioid Control Cohort | Active comparator | One treatment selected:
Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg) Receives: Drug: Tramadol; Drug: Hydrocodone-Acetaminophen; Drug: Oxycodone-Acetaminophen |
| Experimental Cohort | Experimental | Multimodal Approach:
Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4) Receives: Drug: Gabapentin; Drug: Ketorolac; Drug: Acetaminophen; Drug: Ketorolac tromethamine; Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Pain Score
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Measured: 1 hour before surgery
Visual Analogue Pain Score
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Measured: Baseline
Visual Analogue Pain Score
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Measured: Day 1
Visual Analogue Pain Score
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Measured: Day 3
Visual Analogue Pain Score
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Measured: Day 7
Amount of medication used
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Measured: 1 hour before surgery
Amount of medication used
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Measured: Baseline
Amount of medication used
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Measured: Day 1
Amount of medication used
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Measured: Time of Discharge postoperative up to Day 3
Opioid-Related Symptom Distress Scale (ORSDS)
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Measured: 1 hour before surgery
Opioid-Related Symptom Distress Scale (ORSDS)
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Measured: Baseline
Opioid-Related Symptom Distress Scale (ORSDS)
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Measured: Day 1
Opioid-Related Symptom Distress Scale (ORSDS)
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Measured: Day 3
Opioid-Related Symptom Distress Scale (ORSDS)
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study startAug 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: PI left institution and study was not transferred to new PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radical ProstatectomiesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ram Pathak, MD, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939987
- Sponsor's protocol ID
- IRB00074034
- Status last verified
- May 2022
- First submitted
- 1 Jun 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04939987
- Acronym / sponsor ID
- IRB00074034
- Conditions
- Radical Prostatectomies
- Keywords
- opioids, postoperative pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution and study was not transferred to new PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Control Cohort | Active comparator | Drug: Tramadol, Drug: Hydrocodone-Acetaminophen, Drug: Oxycodone-AcetaminophenOne treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg) |
| Experimental Cohort | Experimental | Drug: Gabapentin, Drug: Ketorolac, Drug: Acetaminophen, Drug: Ketorolac tromethamine, Drug: KetamineMultimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- Allergies to any medication involved in the study
- T4 prostate cancer
- incarcerated persons
- chronic narcotic dependence
- any current prescription for narcotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolAlso: OpioidOpioid Control Cohort (One treatment selected) | Drug | Opioid Control Cohort |
| GabapentinExperimental Cohort (Multimodal Approach) | Drug | Experimental Cohort |
| Hydrocodone-AcetaminophenAlso: OpioidOpioid Control Cohort (One treatment selected) | Drug | Opioid Control Cohort |
| Oxycodone-AcetaminophenAlso: OpioidOpioid Control Cohort (One treatment selected) | Drug | Opioid Control Cohort |
| KetorolacExperimental Cohort (Multimodal Approach) | Drug | Experimental Cohort |
| AcetaminophenExperimental Cohort (Multimodal Approach) | Drug | Experimental Cohort |
| Ketorolac tromethamineExperimental Cohort (Multimodal Approach) | Drug | Experimental Cohort |
| KetamineExperimental Cohort (Multimodal Approach) | Drug | Experimental Cohort |
Primary outcome
Visual Analogue Pain Score
Time frame: 1 hour before surgery
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Visual Analogue Pain Score
Time frame: Baseline
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Visual Analogue Pain Score
Time frame: Day 1
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Visual Analogue Pain Score
Time frame: Day 3
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Visual Analogue Pain Score
Time frame: Day 7
Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable
Amount of medication used
Time frame: 1 hour before surgery
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Amount of medication used
Time frame: Baseline
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Amount of medication used
Time frame: Day 1
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Amount of medication used
Time frame: Time of Discharge postoperative up to Day 3
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Opioid-Related Symptom Distress Scale (ORSDS)
Time frame: 1 hour before surgery
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Opioid-Related Symptom Distress Scale (ORSDS)
Time frame: Baseline
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Opioid-Related Symptom Distress Scale (ORSDS)
Time frame: Day 1
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Opioid-Related Symptom Distress Scale (ORSDS)
Time frame: Day 3
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Opioid-Related Symptom Distress Scale (ORSDS)
Time frame: Day 7
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ram Pathak, MD principal investigator
Wake Forest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tramadol, Gabapentin and Hydrocodone-Acetaminophen in people with Radical Prostatectomies, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Pain Score (time frame: 1 hour before surgery). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.