Malignant Neoplasms of Male Genital OrgansPhase 3NCT02740127
Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis
A Phase 3 study testing Caudal Nerve Block (CNB), Ropivacaine and Epinephrine in people with Malignant Neoplasms of Male Genital Organs, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Malignant Neoplasms of Male Genital Organs
- What is being tested?
- Caudal Nerve Block (CNB), Ropivacaine and Epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 10 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that consent to participate.
- Patients undergoing penile prosthesis surgery.
- Patients that are male.
- Patients that are 18 years of age or older.
Who cannot join
- Patients on chronic pain medications (ie. Chronic = more than once every two days for greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs.
- Patients with a BMI > 40.
- Patients with chronic pain syndromes.
- Patients with hypersensitivity to Ropivacaine/amide-type anesthetics.
- Prior surgery of the sacrum.
- Patients taking anti-coagulants or other blood thinning medications prior to surgery during the specified time frames: i) Low molecular weight heparin less than 36 hours prior to surgery. ii) Coumadin less than 5 days prior to surgery. iii) Plavix and NSAIDs less than 7 days prior to surgery.
Show all 9Show fewer
- Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic pain management less than 24 hours prior to surgery
- Patients on Celebrex less than 24 hours prior to surgery
- Patients taking more than 81 mg of Aspirin daily
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery
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.
Read more
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.
Read the detailed description
Study Groups and CNB Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.
- If you are assigned to Group 1, you will receive a CNB and general anesthesia during surgery.
- If you are assigned to Group 2, you will only receive general anesthesia during surgery.
You will not know to which group you have been assigned. The CNB will be given to you while you are under general anesthesia. To receive a CNB, a special needle is inserted at the lower part of the back (near the tailbone). A type of local anesthesia is then injected into the sac surrounding the spinal cord that contains the nerves related to the penis.
All participants will also receive general anesthesia as part of their standard care. You will also receive a separate consent form for the surgery that explains the procedure and its risks, including the risks for general anesthesia.
After Surgery Data Collection:
During the 24 hours after surgery, the study staff will ask you to rate your pain on a scale of 0-10. You will be asked to rate your pain about every 30 minutes while you are in the hospital, but you may be asked to rate your pain more often if needed. It should take less than 5 minutes each time to rate your pain. Depending on how you rate your pain, additional pain drugs may be given to you as part of your standard care.
If you are discharged from the hospital on the same day as your surgery or if you are discharged before a member of the staff can ask you to rate your pain, the study staff will call you within 24 hours after you have been discharged from the hospital. This call should last about 5-10 minutes.
The amount of pain drugs given to you before, during, and after surgery will also be recorded.
About 3 days after your surgery, the study staff will call you to ask about your pain, the amount of pain drugs you have taken, and how satisfied you are with the type of anesthesia and pain control you have received. This call should last about 5-10 minutes.
Length of Study:
Your participation in this study will be over after the phone call about 3 days after your surgery has been completed.
- Being tested
- Caudal Nerve Block (CNB), Ropivacaine, Epinephrine, Decadron, Clonidine
- Keywords
- Malignant neoplasms of male genital organs, Adult Penile Prosthesis Surgery, Caudal nerve block, CNB, General anesthesia, GA, Ropivacaine, Naropin, Epinephrine, Decadron, Dexamethasone, Clonidine, Propofol, Diprivan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Nerve Block (CNB)Procedure or surgery
General anesthesia given in the OR using Propofol titrated for induction. CNB given as bolus injection into the caudal canal in the operating room (OR) by attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10 mg + Clonidine 100 mcg.
RopivacaineDrug
Also called Naropin
Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.
EpinephrineDrug
Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.
DecadronDrug
Also called Dexamethasone
Decadron 10 mg by bolus injection given by anesthesiologist in OR.
ClonidineDrug
Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.
PropofolDrug
Also called Diprivan
General anesthesia given in the OR using Propofol titrated for induction.
Phone CallBehavioural
Study staff calls participant about 3 days after surgery to ask about their pain, amount of pain drugs they have taken, and how satisfied they are with the type of anesthesia and pain control they received. This call should last about 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Caudal Nerve Block + General Anesthesia Group | Experimental | Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.
Study staff calls participant about 3 days after surgery. Receives: Procedure: Caudal Nerve Block (CNB); Drug: Ropivacaine; Drug: Epinephrine; Drug: Decadron; Drug: Clonidine; Drug: Propofol; Behavioral: Phone Call |
| General Anesthesia Alone Group | Active comparator | Participants receive general anesthesia (GA) during surgery without a caudal nerve block.
Study staff calls participant about 3 days after surgery. Receives: Drug: Propofol; Behavioral: Phone Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)
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.
Measured: 24 hours
Secondary outcomes (2)
Post-operative Pain the First 24hrs
To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in decreased immediate postoperative pain in the first 24 hours after surgery compared with patients having only general anesthesia as determined by postop pain score. The mean, median and max pain will be assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10. The NRS will be used verbally. Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
Measured: 24 hours
Length of Hospital Stay
To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in a decreased length of hospital stay compared with patients having only general anesthesia.
Measured: 32 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Neoplasms of Male Genital OrgansStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Bobby Bellard, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740127
- Sponsor's protocol ID
- 2014-0990
- Other IDs
- NCI-2016-00860
- Status last verified
- Jan 2022
- First submitted
- 12 Apr 2016
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery
- ClinicalTrials.gov ID
- NCT02740127
- Acronym / sponsor ID
- 2014-0990
- Keywords
- Malignant neoplasms of male genital organs, Adult Penile Prosthesis Surgery, Caudal nerve block, CNB, General anesthesia, GA, Ropivacaine, Naropin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2016 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 30 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Groups and CNB Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.
- If you are assigned to Group 1, you will receive a CNB and general anesthesia during surgery.
- If you are assigned to Group 2, you will only receive general anesthesia during surgery.
You will not know to which group you have been assigned. The CNB will be given to you while you are under general anesthesia. To receive a CNB, a special needle is inserted at the lower part of the back (near the tailbone). A type of local anesthesia is then injected into the sac surrounding the spinal cord that contains the nerves related to the penis.
All participants will also receive general anesthesia as part of their standard care. You will also receive a separate consent form for the surgery that explains the procedure and its risks, including the risks for general anesthesia.
After Surgery Data Collection:
During the 24 hours after surgery, the study staff will ask you to rate your pain on a scale of 0-10. You will be asked to rate your pain about every 30 minutes while you are in the hospital, but you may be asked to rate your pain more often if needed. It should take less than 5 minutes each time to rate your pain. Depending on how you rate your pain, additional pain drugs may be given to you as part of your standard care.
If you are discharged from the hospital on the same day as your surgery or if you are discharged before a member of the staff can ask you to rate your pain, the study staff will call you within 24 hours after you have been discharged from the hospital. This call should last about 5-10 minutes.
The amount of pain drugs given to you before, during, and after surgery will also be recorded.
About 3 days after your surgery, the study staff will call you to ask about your pain, the amount of pain drugs you have taken, and how satisfied you are with the type of anesthesia and pain control you have received. This call should last about 5-10 minutes.
Length of Study:
Your participation in this study will be over after the phone call about 3 days after your surgery has been completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal Nerve Block + General Anesthesia Group | Experimental | Procedure: Caudal Nerve Block (CNB), Drug: Ropivacaine, Drug: Epinephrine, Drug: Decadron, Drug: Clonidine, Drug: Propofol, Behavioral: Phone CallParticipants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery. Study staff calls participant about 3 days after surgery. |
| General Anesthesia Alone Group | Active comparator | Drug: Propofol, Behavioral: Phone CallParticipants receive general anesthesia (GA) during surgery without a caudal nerve block. Study staff calls participant about 3 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients that consent to participate.
- Patients undergoing penile prosthesis surgery.
- Patients that are male.
- Patients that are 18 years of age or older.
Key exclusion criteria (9 listed)
- Patients on chronic pain medications (ie. Chronic = more than once every two days for greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs.
- Patients with a BMI > 40.
- Patients with chronic pain syndromes.
- Patients with hypersensitivity to Ropivacaine/amide-type anesthetics.
- Prior surgery of the sacrum.
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 |
|---|---|---|
| Caudal Nerve Block (CNB)General anesthesia given in the OR using Propofol titrated for induction. CNB given as bolus injection into the caudal canal in the operating room (OR) by attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10 mg + Clonidine 100 mcg. | Procedure or surgery | Caudal Nerve Block + General Anesthesia Group |
| RopivacaineAlso: NaropinRopivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR. | Drug | Caudal Nerve Block + General Anesthesia Group |
| EpinephrineEpinephrine 1:400,000 by bolus injection given by anesthesiologist in OR. | Drug | Caudal Nerve Block + General Anesthesia Group |
| DecadronAlso: DexamethasoneDecadron 10 mg by bolus injection given by anesthesiologist in OR. | Drug | Caudal Nerve Block + General Anesthesia Group |
| ClonidineClonidine 100 mcg by bolus injection given by anesthesiologist in OR. | Drug | Caudal Nerve Block + General Anesthesia Group |
| PropofolAlso: DiprivanGeneral anesthesia given in the OR using Propofol titrated for induction. | Drug | Caudal Nerve Block + General Anesthesia Group, General Anesthesia Alone Group |
| Phone CallStudy staff calls participant about 3 days after surgery to ask about their pain, amount of pain drugs they have taken, and how satisfied they are with the type of anesthesia and pain control they received. This call should last about 5-10 minutes. | Behavioural | Caudal Nerve Block + General Anesthesia Group, General Anesthesia Alone Group |
Primary outcome
Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)
Time frame: 24 hours
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.
2 secondary outcomes
Post-operative Pain the First 24hrs
Time frame: 24 hours
Length of Hospital Stay
Time frame: 32 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Malignant Neoplasms of Male Genital Organs
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
Malignant Testicular Germ Cell Tumor
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.
Bobby Bellard, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caudal Nerve Block (CNB), Ropivacaine and Epinephrine in people with Malignant Neoplasms of Male Genital Organs, run by M.D. Anderson Cancer Center 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jan 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 30 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU) (time frame: 24 hours). 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 24 Jan 2022.