Postoperative pain and mobilization after radical or nephronsparing nephrectomy in patients with renal cell carcinoma MedDRA version: 13.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Catapresan
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Clonidine HCL
CAS Number: 4205-91-8
Current Sponsor code: klonidin
Other descriptive name: CLONIDINE HYDROCHLORI
Sponsors
Prof. Ola Winsö, Anesthesia and Intensive Care Medicine, Norrlands University Hospiatal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main object is to make the postoperative analgesia better and enhance the mobilization after nephrectomies due to renal cell carcinoma ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Motility index of days 1,2,4,5,6; Daily pain according to the VAS scale Time to first postoperative rescue analgesic Time to surgery from entering the operation theater Dosing of Fenylefrin during surgery. Time at postoperative unit Time to fist bowel delivery Time to discharge from hospital Difference in complications using the Clavian classification Any difference in oxygen concentration, median and systolic artery pressure will be evaluated from the surgery and in the postoperative unit. ;Timepoint(s) of evaluation of this end point: depending on the study variable, se above | — |
Countries
Sweden
Outcome results
None listed