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NCT02740127 · ClinicalTrials.gov registry record · Phase 3
Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis
A Phase 3 study of Malignant Neoplasms of Male Genital Organs, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT02740127: Completed Phase 3 study of Malignant Neoplasms of Male Genital Organs, sponsored by M.D. Anderson Cancer Center.
NCT02740127 is a Phase 3 study of Malignant Neoplasms of Male Genital Organs that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 52 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02740127, a Phase 3 study of Malignant Neoplasms of Male Genital Organs, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which can lower the need for pain drugs. The goal of this clinical research study is to learn how effective CNBs are in patients who are having penile prosthesis surgery compared to patients who only have general anesthesia by studying how long you stay in the hospital and the level of pain you have after surgery. This is an investigational study. The general anesthesia and CNB used in this study are FDA approved and commercially available. It is considered investigational to compare the effectiveness of CNBs in penile prosthesis surgery to general anesthesia alone. The study doctor can explain how the study drugs are designed to work. Up to 104 participants will be enrolled in this study. All will take part at MD Anderson.
Primary Outcome
Pain evaluated by the amount of intravenous and oral pain medicine administered in the first 24 hours post-operatively. Pain assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10, where 0 is no pain and 10 is the worst pain.
Conditions Studied
Interventions
- DRUG Epinephrine
- DRUG Ropivacaine
- DRUG Clonidine
- PROCEDURE Caudal Nerve Block (CNB)
- DRUG Decadron
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2016-06 |
| Est. Completion | 2020-05-10 |
| Phase | Phase 3 |
What the finished NCT02740127 record still lists
NCT02740127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Malignant Neoplasms of Male Genital Organs appearing as the primary indexed condition, and to 5 interventions - of which Epinephrine is the first listed.
NCT02740127 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02740127 about?
NCT02740127 is a clinical study titled "Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis". During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which can lower the need for pain drugs. The goal of this clinical research s...
What is the current status of trial NCT02740127?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2016-06. Estimated completion is 2020-05-10.
What conditions does trial NCT02740127 study?
This clinical trial studies the following conditions: Malignant Neoplasms of Male Genital Organs.
What interventions are being tested in trial NCT02740127?
The interventions under investigation include: Epinephrine (DRUG), Ropivacaine (DRUG), Clonidine (DRUG), Caudal Nerve Block (CNB) (PROCEDURE), Decadron (DRUG).
Who is sponsoring clinical trial NCT02740127?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02740127 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02740127's enrollment target sits among peer trials
52 1841st of 2000 higher than 159 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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