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Phase 3 Completed N=25 Randomized Double-blind Supportive Care

Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy

Source: ClinicalTrials.gov NCT02355886 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) — 297.65; 396.16 Total oral morphine equivalents in mg
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
297.65; 396.16
SECONDARY
Length of Stay Following Radical Cystectomy
6.58; 6.73
SECONDARY
Patient Self-assessed Pain on Numerical Pain Scale
5.15; 7.67

Eligibility Criteria

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 90 days)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02355886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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