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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jasminka Persec, MD, PhD, University Hospital Dubrava
ClinicalTrials.gov Identifier:
NCT00860899
First received: March 10, 2009
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Analgesia
Pain
Systemic Inflammatory Stress Response
Drug: clonidine, levobupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Postoperative Pain and Systemic Inflammatory Stress Response (SIRS) After Preoperative Analgesia With Clonidine or Levobupivacaine

Resource links provided by NLM:


Further study details as provided by University Hospital Dubrava:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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]

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

Ages Eligible for Study:   42 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00860899

Locations
Croatia
University Hospital Dubrava
Zagreb, Croatia, 10000
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Jasminka Persec, MD, PhD, MD PhD, University Hospital Dubrava
ClinicalTrials.gov Identifier: NCT00860899     History of Changes
Other Study ID Numbers: 1860, 1861
Study First Received: March 10, 2009
Last Updated: November 16, 2011
Health Authority: Croatia: Ethics Committee

Keywords provided by University Hospital Dubrava:
clonidine
levobupivacaine
preoperative analgesia
postoperative pain
systemic inflammatory stress response
epidural analgesia
Anesthetics, Local

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Levobupivacaine
Bupivacaine
Clonidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local

ClinicalTrials.gov processed this record on August 28, 2014