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NCT04939987
Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
Withdrawn
Phase 2/Phase 3
Last updated 31 August 2022
What this trial tests
Phase 2/Phase 3 trial testing Tramadol in Radical Prostatectomies. Withdrawn.
Timeline
1 August 2022
Primary endpoint
1 October 2022
1 October 2022
1 October 2022
Quick facts
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 August 2022 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 October 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tramadol (tramadol) — full drug profile →
- Gabapentin (Gabapentin) — full drug profile →
- Hydrocodone-Acetaminophen
- Oxycodone-Acetaminophen
- Ketorolac (KETOROLAC) — full drug profile →
- Acetaminophen (Paracetamol) — full drug profile →
- Ketorolac tromethamine
- Ketamine (ketamine) — full drug profile →
Conditions studied
- Radical Prostatectomies — all drugs for Radical Prostatectomies →
Sponsor
Wake Forest University Health Sciences
Who can join
Adults 40 to 75, male only, with Radical Prostatectomies. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04939987
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04939987 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
- Last refreshed: 31 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04939987.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing