Bladder spasm following endoscopic resection for: Bladder tumour Prostate hypertrophy Prostate cancer
Conditions
Interventions
Trade Name: Sublimaze
Product Name: Sublimaze
Pharmaceutical Form: Injection*
INN or Proposed INN: Fentanyl citrate
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and Female: Aged over 18 years. There is no upper age limit. Scheduled for bladder outlet surgery Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: INR > 1.5 on the day of surgery Pregnant or lactating women- a pregnancy test will be carried out if there is any risk of the patient being pregnant. Platelet count 40mg once daily) Allergy or intolerance to local anaesthetics or fentanyl Current administration of monamine oxidase inhibitors Other contraindications to caudal epidural analgesia such as local sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is a caudal epidural injection of local anaesthetic more effective than simple intravenous analgesia at relieving post operative bladder spasm after endoscopic urological surgery?;Secondary Objective: Is a caudal epidural injection of local anaesthetic more effective than simple intravenous analgesia at relieving nausea and vomiting after endoscopic urological surgery?;Primary end point(s): 24 hours following the end of surgery for each patient. | — |
Countries
United Kingdom
Outcome results
None listed