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Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine

NCT ID: NCT00860899

Last Updated: 2011-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Analgesia Pain Systemic Inflammatory Stress Response

Keywords

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clonidine levobupivacaine preoperative analgesia postoperative pain systemic inflammatory stress response epidural analgesia Anesthetics, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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clonidine

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.

Group Type ACTIVE_COMPARATOR

clonidine, levobupivacaine

Intervention Type DRUG

One hour prior to skin incision, on epidural catheter, patients received 5 µg/kg of clonidine \[Catapres®, Boehringer Ingelheim, Germany\], 7 mL of 0.25% levobupivacaine \[Chirocaine®, Abbott S.p.A., Italy\] or 7 mL of saline.The study was designed to compare clonidine and levobupivacaine, and than both with the control group, in order to asses their analgesic and immunomodulation efficacy.

levobupivacaine

Levobupivacaine is long-acting local anesthetic, S-enantiomer of bupivacaine, with identical anesthetic potency.

Group Type ACTIVE_COMPARATOR

clonidine, levobupivacaine

Intervention Type DRUG

One hour prior to skin incision, on epidural catheter, patients received 5 µg/kg of clonidine \[Catapres®, Boehringer Ingelheim, Germany\], 7 mL of 0.25% levobupivacaine \[Chirocaine®, Abbott S.p.A., Italy\] or 7 mL of saline.The study was designed to compare clonidine and levobupivacaine, and than both with the control group, in order to asses their analgesic and immunomodulation efficacy.

Interventions

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clonidine, levobupivacaine

One hour prior to skin incision, on epidural catheter, patients received 5 µg/kg of clonidine \[Catapres®, Boehringer Ingelheim, Germany\], 7 mL of 0.25% levobupivacaine \[Chirocaine®, Abbott S.p.A., Italy\] or 7 mL of saline.The study was designed to compare clonidine and levobupivacaine, and than both with the control group, in order to asses their analgesic and immunomodulation efficacy.

Intervention Type DRUG

Other Intervention Names

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clonidine [Catapres®, Boehringer Ingelheim, Germany] levobupivacaine [Chirocaine®, Abbott S.p.A., Italy]

Eligibility Criteria

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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
Minimum Eligible Age

42 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

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Jasminka Persec, MD, PhD

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jasminka Persec, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava

Zoran Persec, MD Msc

Role: STUDY_CHAIR

Department of Urology, University Hospital Dubrava

Ino Husedzinovic, Prof. MD PhD

Role: STUDY_DIRECTOR

Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava

Locations

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University Hospital Dubrava

Zagreb, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type BACKGROUND

Other Identifiers

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1861

Identifier Type: -

Identifier Source: secondary_id

1860

Identifier Type: -

Identifier Source: org_study_id