Bladder Carcinoma
Conditions
Brief summary
This randomized phase II/III trial studies gabapentin in reducing the need for pain medication in patients with bladder cancer undergoing surgery to remove the bladder and nearby tissue and organs. Gabapentin may reduce the amount of pain medicine required after surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.
Detailed description
PRIMARY OBJECTIVES: I. To assess if perioperative gabapentin will decrease post-operative analgesic requirements within the first 48 hours after radical cystectomy (RC) in patients undergoing RC as measured morphine equivalents. SECONDARY OBJECTIVES: I. To assess patient self-assessment of postoperative pain on Numeric Pain Scale (NPS) at 24 and 48 hours. II. To assess time to return of bowel function (ROBF). III. To assess length of stay (LOS) following RC. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gabapentin orally (PO) thrice daily (TID) for 48 hours after surgery. ARM II: Patients receive placebo PO TID for 48 hours after surgery.
Interventions
DRUGGabapentin
Given PO
OTHERPlacebo
Given PO
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bladder cancer * Anticipated radical cystectomy with ileal conduit or orthotopic neobladder
Exclusion criteria
* Presence of spinal cord injury including any form of paraplegia or quadriplegia * Allergy to gabapentin * Active alcohol dependence, defined as 2 or more positive questions on the CAGE alcoholism questionnaire * Illicit drug use (excluding recreational marijuana) * Chronic kidney disease with glomerular filtration rate \< 30 ml/min * Pregnancy: All female patients \< 55 years old (yo) will be administered a urine pregnancy test prior to enrollment * Non-English speaking patients * Chronic gabapentin, or the similar drug pregabalin, use * Chronic narcotic use (daily or near daily use for \> 90 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) | 48 hours post-radical cystectomy | Geometric Mean and Standard Deviation of patient total equivalent analgesic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay Following Radical Cystectomy | duration of hospital stay. Days to weeks | The two study groups will be compared by Length of stay following radical cystectomy |
| Patient Self-assessed Pain on Numerical Pain Scale | Up to 48 hours post-radical cystectomy | The two study groups compared on Patient self-assessed pain on numerical pain likert scale. Numeric Pain Scale was utilized with values of 0-10 with increasing severity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Gabapentin) Patients receive gabapentin PO TID for 48 hours after surgery.
Gabapentin: Given PO
Questionnaire Administration: Ancillary studies | 13 |
| Arm II (Placebo) Patients receive placebo PO TID for 48 hours after surgery.
Placebo: Given PO
Questionnaire Administration: Ancillary studies | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Arm I (Gabapentin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Age, Continuous | 66.82 years STANDARD_DEVIATION 9.69 | 68.33 years STANDARD_DEVIATION 8.39 | 67.5 years STANDARD_DEVIATION 9.31 |
| neoadjuvant chemotherapy | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 00 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 12 Participants | 25 Participants |
| Region of Enrollment United States | 13 participants | 12 participants | 25 participants |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 6 / 13 | 10 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
Geometric Mean and Standard Deviation of patient total equivalent analgesic
Time frame: 48 hours post-radical cystectomy
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Gabapentin) | Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) | 297.65 Total oral morphine equivalents in mg | Standard Deviation 179.95 |
| Arm II (Placebo) | Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) | 396.16 Total oral morphine equivalents in mg | Standard Deviation 149.84 |
Secondary
Length of Stay Following Radical Cystectomy
The two study groups will be compared by Length of stay following radical cystectomy
Time frame: duration of hospital stay. Days to weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Gabapentin) | Length of Stay Following Radical Cystectomy | 6.58 days | Standard Deviation 1.98 |
| Arm II (Placebo) | Length of Stay Following Radical Cystectomy | 6.73 days | Standard Deviation 2.83 |
Secondary
Patient Self-assessed Pain on Numerical Pain Scale
The two study groups compared on Patient self-assessed pain on numerical pain likert scale. Numeric Pain Scale was utilized with values of 0-10 with increasing severity.
Time frame: Up to 48 hours post-radical cystectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Gabapentin) | Patient Self-assessed Pain on Numerical Pain Scale | 5.15 Sore on a scale | Standard Deviation 2.8 |
| Arm II (Placebo) | Patient Self-assessed Pain on Numerical Pain Scale | 7.67 Sore on a scale | Standard Deviation 1.89 |