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Gabapentin and CRBD

Efficacy of Gabapentin for Prevention of Postoperative Catheter-related Bladder Discomfort in Patients Undergoing open prostatectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014063017811N4
Enrollment
42
Registered
2014-07-06
Start date
2013-08-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Catheter-related Bladder Discomfort in Patients Undergoing open prostatectomy. Mechanical complication of urinary (indwelling) catheter

Interventions

Intervention 1: patients in gabapentin group will received the study drug orally with sips of water 2 hours before the administration of spinal anesthesia then they will receive gabapentin capsules 1
Treatment - Drugs
patients in gabapentin group will received the study drug orally with sips of water 2 hours before the administration of spinal anesthesia then they will receive gabapentin capsules 100 mg per 8 hour
matching placebo capsules contain starch will be given to placebo group

Sponsors

Arak University of Medical Science,Office of Vice Chancellor for Research
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: inclusion criteria: Patients of American Society of Anesthesiologists (ASA) physical status I-II undergoing elective open prostatectomy surgery under spinal anesthesia ; requiring catheterization of the urinary bladder ; 50–80 kg of weight exclusion criteria: Patients with history of OAB (urinary frequency >3 times at night and > 8 times in 24 hours) ; neurogenic bladder; diabetes mellitus ; Parkinson’s disease and impaired renal function ; chronic use of opiates or sedatives ; antiacid uptake in the past 48 hours ; hypersensitivity to amide local anesthetics or gabapentin

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Catheter-related bladder discomfort(CRBD) severity. Timepoint: at hours 2,5,24,48,72 after surgery. Method of measurement: based on asking patients based on Likert scale.;Pain severity. Timepoint: at hours 2,5,24,48,72 after surgery. Method of measurement: based on VAS index.

Secondary

MeasureTime frame
Total morphine requirement. Timepoint: at hours 2,6,24,48,72. Method of measurement: counting amount of morphine that will be injected to patient.;Postoperative sedation. Timepoint: at hours 2,6,24,48,72. Method of measurement: clinical examination.;Postoperative N/V. Timepoint: at hours 2,6,24,48,72. Method of measurement: clinical examination and history taking.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Aghamohammadi

Medicine faculty , Aarak University of Medical Science

javad.aghamohammadi@yahoo.com+98 86 3417 3502

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026