Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine

Phase 4

Completed

• Conditions: Analgesia; Pain; Systemic Inflammatory Stress Response
• Interventions: Drug: clonidine, levobupivacaine

• Registration Number: NCT00860899
• Lead Sponsor: University Hospital Dubrava

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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-10
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Study Completion: 2009-05
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clonidine	clonidine, levobupivacaine	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.
levobupivacaine	clonidine, levobupivacaine	Levobupivacaine is long-acting local anesthetic, S-enantiomer of bupivacaine, with identical anesthetic potency.

Primary Outcome Measures

Name	Time	Method
postoperative pain level	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

Name	Time	Method
systemic inflammatory stress response	1 hour before surgery, 1 hour after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery

Trial Locations

Locations (1)

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia