Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine (PPSAPACL)

November 16, 2011 updated by: Jasminka Persec, MD, PhD, University Hospital Dubrava

Postoperative Pain and Systemic Inflammatory Stress Response (SIRS) After Preoperative Analgesia With Clonidine or Levobupivacaine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Dubrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

42 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Other Names:
  • clonidine [Catapres®, Boehringer Ingelheim, Germany]
  • levobupivacaine [Chirocaine®, Abbott S.p.A., Italy]
Active Comparator: levobupivacaine
Levobupivacaine is long-acting local anesthetic, S-enantiomer of bupivacaine, with identical anesthetic potency.
Drug: 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.
Other Names:
  • clonidine [Catapres®, Boehringer Ingelheim, Germany]
  • levobupivacaine [Chirocaine®, Abbott S.p.A., Italy]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative pain level
Time Frame: 1 h before surgery, 1 h after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery
1 h before surgery, 1 h after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
systemic inflammatory stress response
Time Frame: 1 hour before surgery, 1 hour after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery
1 hour before surgery, 1 hour after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Dubrava

Investigators

  • Principal Investigator: Jasminka Persec, MD PhD, Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava
  • Study Chair: Zoran Persec, MD Msc, Department of Urology, University Hospital Dubrava
  • Study Director: Ino Husedzinovic, Prof. MD PhD, Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

November 16, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1860
  • 1861

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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