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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


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.


Minimum age: 42 Years. Maximum age: 77 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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