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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2012/005 |
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Date of registration:
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10/06/2012 |
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Primary sponsor: |
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Public title:
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Effects of acute postoperative pain management on the body's stress response
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Scientific title:
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Effects of acute postoperative pain management on the body's stress response |
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Date of first enrolment:
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11/6/2012 |
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Target sample size:
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60 patients (20 in each group) |
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Recruitment status: |
Pending |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={077B9999-351D-47DE-982D-01A69B2AAB47} |
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Study type:
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Interventional |
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Study design:
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Prospective, randomized, controlled, single center, open study
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Vilka Bekavac Misak
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Address:
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Department of Anesthesiology, REanimatology, and Intensive Care, Zagreb University Hospital Center, Kišpatiand#263;eva 12, Zagreb 10000, Croatia
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Telephone:
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++385-1-2388-509 |
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Email:
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vilka.bekavac.misak@gmail.com |
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Affiliation:
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M.D. |
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Name:
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Vilka Bekavac Mišak
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Address:
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Department of Anesthesiology, REanimatology, and Intensive Care, Zagreb University Hospital Center, Kišpatiand#263;eva 12, Zagreb 10000, Croatia
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Telephone:
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++385-1-2388-509 |
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Email:
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vilka.bekavac.misak@gmail.com |
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Affiliation:
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M.D. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Postoperative pain after lumbotomy incision
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Intervention(s)
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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.
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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Decrease in the visual analogue scale (VAS) score; changes in clinical status (ECG, SaO2, BP, HR), and occurence of complications (atelectasis, pneumonia).
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Secondary ID(s)
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1080000000-0008 (Ministry of Science, Education, and Sports of the Republic of Croatia)
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Source(s) of Monetary Support
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The Ministry of Science, Education, and Sports of the Republic of Croatia (Project No.: 1080000000-0008)
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