Randomized study comparing spinal anealgesia compared with epidural analgesia durinmg and postoperative nephrectomy dua to renal cell carcinoma
- Conditions
- Postoperative pain and mobilization after radical or nephronsparing nephrectomy in patients with renal cell carcinomaMedDRA version: 13.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-001491-77-SE
- Lead Sponsor
- Prof. Ola Winsö, Anesthesia and Intensive Care Medicine, Norrlands University Hospiatal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients planned to perform nephrectomy due to renal cell carcinoma, having a ASA score between I and III.
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 of patients having a ASA score more than III, or patients having a high risk for bleeding during surgery as vena caval thrombosis; Patients with chronic pain disorders; Patients with any abuse; Patients younger than 18 years old and uncapable of understanding the consent form will not be eligible; Pregnant women or when pregnancy cannot be ruled out; All patients with any contraindication for epidural- or spinal analgesia will be excluded. As well as patients having a body weight less than 45 kg or more than 120 kg.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main object is to make the postoperative analgesia better and enhance the mobilization after nephrectomies due to renal cell carcinoma<br><br>;Secondary Objective: Better analgesia and mobilization can give the patients earlier recover and shorter hospitalization. Furthermore the use of urinary catheters can be shortened as well as a lower use of analgesics. Other secondary objectives are that the spinal method can shorten the procedures in the operation theater and have lower costs. ;Primary end point(s): A better patients’ mobility index” is expected in the group of patients with spinal analgesia. This motility index is based on: postoperative pain, unwell, need for intravenous fluid, and mobilization factors as: walking in corridor, flatulence, getting out of bed without help, urinary bladder catheter and eating in dining room.;Timepoint(s) of evaluation of this end point: 3rd day
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Motility index of days 1,2,4,5,6; <br>Daily pain according to the VAS scale<br>Time to first postoperative rescue analgesic<br>Time to surgery from entering the operation theater <br>Dosing of Fenylefrin during surgery.<br>Time at postoperative unit<br>Time to fist bowel delivery<br>Time to discharge from hospital<br>Difference in complications using the Clavian classification<br>Any difference in oxygen concentration, median and systolic artery pressure will be evaluated from the surgery and in the postoperative unit.<br>;Timepoint(s) of evaluation of this end point: depending on the study variable, se above