Postoperative pain and recovery after robot assisted laparoscopic prostatectomy - a single-blinded randomized controlled trial
- Conditions
- Postoperative pain and recovery after robot assisted laparoscopic prostatectomyMedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863Therapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2018-003806-23-SE
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 200
Patients > 18 years
ASA I-III
undergoing RALP
signed 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
• Chronic opiate medication (> 3 months preoperatively)
• Contraindication to spinal anesthesia or allergy to any component drugs used during spinal anesthesia or any other contraindications to the use of other study drugs used
• Patient with uncontrolled renal, liver, heart failure or ischemic heart disease
• Ongoing gastric ulcer
• GI bleeding or other forms of acute bleeding/shock
• Pre-existing respiratory depression
• Sepsis or other ongoing infections
• Coagulation problems or simultaneous administration of therapeutic doses of anticoagulants
• Patients with speech, language or cognitive difficulties
• Patients living alone or having no adult at home to look after them during the first 24 h after home discharge
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method