Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine
Condition: Analgesia; Pain; Systemic Inflammatory Stress Response
MeSH terms: Agnosia; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): clonidine, levobupivacaine
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): clonidine [Catapres®, Boehringer Ingelheim, Germany]; levobupivacaine [Chirocaine®, Abbott S.p.A., Italy]
Intervention MeSH terms: Clonidine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: clonidine; levobupivacaine; preoperative analgesia; postoperative pain; systemic inflammatory stress response; epidural analgesia; Anesthetics, Local