Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine
Information source: University Hospital Dubrava
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Analgesia; Pain; Systemic Inflammatory Stress Response
Intervention: clonidine, levobupivacaine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital Dubrava Official(s) and/or principal investigator(s):
Jasminka Persec, MD PhD, Principal Investigator, Affiliation: Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava
Zoran Persec, MD Msc, Study Chair, Affiliation: Department of Urology, University Hospital Dubrava
Ino Husedzinovic, Prof. MD PhD, Study Director, Affiliation: Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava
Summary
The purpose of this study was to investigate hypothesis that preoperative administration of
epidural clonidine will reduce postoperative pain and systemic inflammatory stress response
better than epidural levobupivacaine.
Clinical Details
Official title: Postoperative Pain and Systemic Inflammatory Stress Response (SIRS) After Preoperative Analgesia With Clonidine or Levobupivacaine
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: postoperative pain level
Secondary outcome: systemic inflammatory stress response
Detailed description:
Investigations showed that upregulation of prostaglandin E2 and interleukin-6 at central
sites is an important component of surgery induced inflammatory response in patients.
Postoperative period is associated with an increased production of cytokines, which augment
pain sensitivity. With adequate perioperative pain control it is possible to control central
and peripheral inflammatory response to surgery, and influence on patient outcomes. Use of
analgetics before the pain stimulus (preventive analgesia) prevent development of
neuroplastic changes in central nervous system, and reduces pain. Clonidine is an
alpha2-adrenergic agonist with sedative, analgesic and hemodynamic properties. It inhibits
transmission of nociceptive stimuli in the dorsal horn of the spinal cord, acting on the
inhibitory descending pathways. According to recent experimental investigations clonidine
lowers proinflammatory cytokine level, and prevents hypersensitization acting through
adrenoreceptors alpha-2A.
Levobupivacaine is a long-acting local anesthetic, S-enantiomer of bupivacaine, with
identical anesthetic potency. When administered intraperitoneally or by local infiltration
of operation site, levobupivacaine produced analgesia and reduction of proinflammatory
cytokines. Investigations of epidural and intrathecal levobupivacaine provide evidence for
improved postoperative analgesia with reduced analgesic consumption. But, it remains unknown
if that analgesia is sufficient enough to blockade inflammatory stress response during
perioperative time. We want to investigate and compare analgesic and immunomodulation
efficacy of this two frequently used analgesics.
Eligibility
Minimum age: 42 Years.
Maximum age: 77 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- colorectal resection surgery patients
- preoperative risk of anesthesia and operation, ASA (American Society of
Anesthesiologists) physical status I or II
Exclusion Criteria:
- diabetes mellitus
- renal insufficiency
- liver insufficiency
- autoimmune disease
- corticosteroid and immunosuppressive use
- operation time exceeding six hours
Locations and Contacts
University Hospital Dubrava, Zagreb 10000, Croatia
Additional Information
Related publications: 1. Buvanendran A, Kroin JS, Berger RA, Hallab NJ, Saha C et al.Anesthesiology 104(3):403-410, 2006. 2. Katz J. Curr Opin Anaesthesiol 15(4):435-441, 2002. 3. Carr DB. Anesthesiology 85(6): 1498-1499, 1996. 4. Lavand'homme PM, Eisenach JC. Pain 105(1-2):247-254, 2003. 5. Nader ND, Ignatowski TA, Kurek CJ, Knight PR, Spengler RN. Anesth Analg 93(2):363-369, 2001. 6. Wu CT, Jao SW, Borel CO, Yeh CC, Li CY, Lu CH et al. Anesth Analg 99(2):502-509, 2004. 7. Novak-Jankovic V, Bovill JG, Ihan A, Osredkar J. Eur J Anaesthesiology 17(1):50-56, 2000. 8. Kim MH, Hahn TH. Anesth Analg 90(6):1441-1444, 2000. 9. Louizos AA, Hadzilia SJ, Leandros E, Kouroukli IK, Georgiou LG et al. Surg Endosc 19(11):1503-1506, 2005. 10. Meisner M, Brunkhorst FM, Reith HB, Schmidt J, Lestin HG et al. Clin Chem Lab Med 38(10):989-995, 2000. 11. Naeini AE, Montazerolghaem S. Saudi Med J 27(3):422-424, 2006. 12. Sarbinowski R, Arvidsson S, Tylman M, Oresland T, Bengtsson A. Acta Anaesthesiol Scand 49(2):191-196, 2005.
Starting date: December 2007
Last updated: November 16, 2011
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