Home » Trials » SLCTR/2012/005
Effects of acute postoperative pain management on the body's stress response
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SLCTR Registration Number
SLCTR/2012/005
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effects of acute postoperative pain management on the body's stress response
Public Title of Trial
Effects of acute postoperative pain management on the body's stress response
Disease or Health Condition(s) Studied
Postoperative pain after lumbotomy incision
Scientific Acronym
None
Public Acronym
None
Brief title
Pain management and stress response
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
1080000000-0008 (Ministry of Science, Education, and Sports of the Republic of Croatia)
What is the research question being addressed?
Is neurohumoral, metabolic, and immunologic stress response lower with the administration of multimodal, balanced epidural analgesia in comparison with intravenous analgesia, both carefully titrated according to the patient needs?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
Patients undergoing lumbotomy will be randomized into 3 groups. The first group will receive continuous intravenous infusion of sufentanil and ketamine. The second group will receive continuous epidural infusion of levobupivacaine and sufentanil (epidural catheter will be placed a day before surgery). The third (control) group will receive continuous intravenous infusion of tramadol and metamizole sodium with an intravenous injection of non-steroidal anti-inflammatory drug. All patients will receive identical endotracheal anaesthesia according to the good clinical practice. All patients will be operated on in the same surgical position, under the same conditions, by the same surgeons (four) using the same surgical technique and instruments
Inclusion criteria
Adult patients (aged more than 18 years) ASA I and II undergoing open kidney surgery with lumbotomy (nephrectomy, nephrolithotomy, pyeloplastic surgery, kidney resection, adrenalectomy).
Exclusion criteria
Patients with ASA III and IV, diabetes mellitus, advanced cancer, psychiatric disorders, cognitive deficits, and taking immunosupressive therapy
Primary outcome(s)
|
1.
Differences between three groups in the levels of metabolic markers (leukocyte count, lymphocyte count, CRP, fibrinogen, and blood glucose), stress hormones (prolactin, cortisol, adrenalin), and cytokines (interleukin IL-1, IL-6, IL-1RA). |
[ Preoperatively and 4, 24, and 48 hours after induction of analgesia. ] |
Secondary outcome(s)
|
1.
Decrease in the visual analogue scale (VAS) score; changes in clinical status (ECG, SaO2, BP, HR), and occurence of complications (atelectasis, pneumonia). |
[ Every 4 hours in the first 48 hours postoperatively. ] |
Target number/sample size
60 patients (20 in each group)
Countries of recruitment
Croatia
Anticipated start date
2012-06-11
Anticipated end date
2012-12-12
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
The Ministry of Science, Education, and Sports of the Republic of Croatia (Project No.: 1080000000-0008
Regulatory approvals
Status
Approved
Date of Approval
2008-06-27
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Committee of the Zagreb University Hospital Centre and School of Medicine |
| Institutional Address: | Zagreb, Croatia |
| Telephone: | Not Available |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
Vilka Bekavac Misak M.D.
Department of Anesthesiology, REanimatology, and Intensive Care, Zagreb University Hospital Center, Kišpati?eva 12, Zagreb 10000, Croatia
++385-1-2388-509 ++385-1-2421-601
vilka.bekavac.misak@gmail.com
Contact Person for Public Queries
Vilka Bekavac Misak M.D.
Department of Anesthesiology, REanimatology, and Intensive Care, Zagreb University Hospital Center, Kišpati?eva 12, Zagreb 10000, Croatia
++385-1-2388-509 ++385-1-2421-601
vilka.bekavac.misak@gmail.com
Primary study sponsor/organization
The Ministry of Science, Education, and Sports of the Republic of Croatia
Donje svetice 38, Zagreb, Croatia
++385-1 45 69 000
http://public.mzos.hr/Default.aspx?sec=2428
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
