Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
NCT Number: NCT02355886
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 2 / Phase 3
Seattle, Washington, 98109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Given PO
Other names: Gralise, Neurontin
Given PO
Other names: placebo therapy, PLCB, sham therapy
Ancillary studies
Time frame: 48 hours post-radical cystectomy
Geometric Mean and Standard Deviation of patient total equivalent analgesic
Time frame: duration of hospital stay. Days to weeks
The two study groups will be compared by Length of stay following radical cystectomy
Time frame: 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.
University of Washington
Other
Randomized Placebo Control Trial of Perioperative Gabapentin to Reduce Total Analgesic Requirements in Patients Undergoing Radical Cystectomy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04502095
Bladder Carcinoma, Female Urogenital Diseases
Buffalo, New York, United States
View Trial DetailsNCT02439060
Bladder Carcinoma, Female Urogenital Diseases
Los Angeles, California, United States
View Trial DetailsNCT06789224
Abdominal Neoplasms, Adenocarcinoma
Cologne, North Rhine-Westphalia, Germany
View Trial DetailsNCT05399004
Bladder Carcinoma, Female Urogenital Diseases
Washington D.C., District of Columbia, United States
View Trial Details