Malignant Neoplasms of Male Genital Organs
Conditions
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
Brief 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.
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.
Interventions
PROCEDURECaudal 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.
DRUGRopivacaine
Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.
DRUGEpinephrine
Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.
DRUGDecadron
Decadron 10 mg by bolus injection given by anesthesiologist in OR.
DRUGClonidine
Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.
DRUGPropofol
General anesthesia given in the OR using Propofol titrated for induction.
BEHAVIORALPhone Call
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.
Sponsors
Merck Sharp & Dohme LLC
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients that consent to participate. 2. Patients undergoing penile prosthesis surgery. 3. Patients that are male. 4. Patients that are 18 years of age or older.
Exclusion criteria
1. Patients on chronic pain medications (ie. Chronic = more than once every two days for greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs. 2. Patients with a BMI \> 40. 3. Patients with chronic pain syndromes. 4. Patients with hypersensitivity to Ropivacaine/amide-type anesthetics. 5. Prior surgery of the sacrum. 6. 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. 7. Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic pain management less than 24 hours prior to surgery 8. Patients on Celebrex less than 24 hours prior to surgery 9. Patients taking more than 81 mg of Aspirin daily
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain the First 24hrs | 24 hours | 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' |
| Length of Hospital Stay | 32 Hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| General Anesthesia and Caudal Nerve Block If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated. | 24 |
| General Anesthesia Only Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated. | 28 |
| Total | 52 |
Baseline characteristics
| Characteristic | General Anesthesia Only | Total | General Anesthesia and Caudal Nerve Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 32 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 28 participants | 52 participants | 24 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 28 Participants | 52 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 28 |
| other Total, other adverse events | 0 / 24 | 0 / 28 |
| serious Total, serious adverse events | 0 / 24 | 0 / 28 |
Outcome results
Primary
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia and Caudal Nerve Block | Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU) | 13.0208 mg | Standard Deviation 11.6362 |
| General Anesthesia Only | Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU) | 15.1786 mg | Standard Deviation 16.6022 |
Secondary
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.
Time frame: 32 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia and Caudal Nerve Block | Length of Hospital Stay | 24.8424 Hours | Standard Deviation 4.9821 |
| General Anesthesia Only | Length of Hospital Stay | 24.9506 Hours | Standard Deviation 2.4564 |
Secondary
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'
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| General Anesthesia and Caudal Nerve Block | Post-operative Pain the First 24hrs | Min Pain within 24hrs | 1.1667 score on a scale | Standard Deviation 130.77 |
| General Anesthesia and Caudal Nerve Block | Post-operative Pain the First 24hrs | Median Pain within 24 hrs | 3.0833 score on a scale | Standard Deviation 2.2778 |
| General Anesthesia and Caudal Nerve Block | Post-operative Pain the First 24hrs | Max Pain within 24 hrs | 6.125 score on a scale | Standard Deviation 2.6096 |
| General Anesthesia Only | Post-operative Pain the First 24hrs | Min Pain within 24hrs | 0.9286 score on a scale | Standard Deviation 1.3859 |
| General Anesthesia Only | Post-operative Pain the First 24hrs | Median Pain within 24 hrs | 3.7143 score on a scale | Standard Deviation 1.8926 |
| General Anesthesia Only | Post-operative Pain the First 24hrs | Max Pain within 24 hrs | 6.7857 score on a scale | Standard Deviation 2.0612 |