Clinical trial NCT00860899: Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine
Official title: Postoperative Pain and Systemic Inflammatory Stress Response (SIRS) After Preoperative Analgesia With Clonidine or Levobupivacaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Pain
Systemic Inflammatory Stress Response
Keywords: clonidine
levobupivacaine
preoperative analgesia
postoperative pain
systemic inflammatory stress response
epidural analgesia
Anesthetics, Local
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 42
Sex: ALL
Minimum age (years): 42
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: postoperative pain level
timeFrame: 1 h before surgery, 1 h after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery
Secondary outcomes:
measure: systemic inflammatory stress response
timeFrame: 1 hour before surgery, 1 hour after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
Study officials:
affiliation: Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava
name: Jasminka Persec, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Urology, University Hospital Dubrava
name: Zoran Persec, MD Msc
role: STUDY_CHAIR
affiliation: Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava
name: Ino Husedzinovic, Prof. MD PhD
role: STUDY_DIRECTOR
References:
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