Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jasminka Persec, MD, PhD, University Hospital Dubrava
ClinicalTrials.gov Identifier:
NCT01739270
First received: November 25, 2012
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.


Condition Intervention
Brachial Plexus Anesthesia
Analgesia
Procedure: supraclavicular brachial plexus block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia After Supraclavicular Brachial Plexus Blockade

Resource links provided by NLM:


Further study details as provided by University Hospital Dubrava:

Primary Outcome Measures:
  • duration of analgesia [ Time Frame: 24 hour postoperatively ] [ Designated as safety issue: Yes ]
    Duration of analgesia after supraclavicular block


Secondary Outcome Measures:
  • postoperative analgesic consumption [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: October 2012
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dexamethasone with levobupivacaine
25ml 0.5% levobupivacaine plus 4mg Dexamethasone are given for supraclavicular brachial plexus block for upper extremity surgery
Procedure: supraclavicular brachial plexus block
Active Comparator: levobupivacaine
25ml 0.5% levobupivacaine plus 1ml 0.9% saline are given for supraclavicular brachial plexus block for upper extremity surgery
Procedure: supraclavicular brachial plexus block

Detailed Description:

Operations of upper extremities are often performed in regional anesthesia blocks. Single-injection blocks are effective, but time limited. Adding 4mg of dexamethasone to 0.5% levobupivacaine will significantly prolong duration of brachial plexus anesthesia and analgesia for fracture operations of upper extremity. This effect will result in less opioid use postoperatively.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 18 years or older
  • ASA (American Society of Anesthesiologists) physical status I, II or III

Exclusion Criteria:

  • refusal of the patients to give informed consent
  • preexisting coagulation disorders
  • local infection at the site of the block
  • neuropathy
  • drug or alcohol abusers
  • known allergy to the drug used in study
  • operation time exceeding six hours
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01739270

Locations
Croatia
Clinical Hospital Dubrava
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital Dubrava
Investigators
Study Chair: Ino Husedzinovic, Professor Clinical Hospital Dubrava, Head of Anesthesiology, Resuscitation and Intensive Care Medicine
  More Information

Publications:
Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6.

Responsible Party: Jasminka Persec, MD, PhD, Anesthesiology, Resuscitation and Intensive Care Medicine Specialist, University Hospital Dubrava
ClinicalTrials.gov Identifier: NCT01739270     History of Changes
Other Study ID Numbers: 0911
Study First Received: November 25, 2012
Last Updated: January 25, 2013
Health Authority: Croatia: Ministry of Science, Education and Sports

Keywords provided by University Hospital Dubrava:
analgesia
regional anesthesia
surgery
duration of analgesia
dexamethasone added to levobupivacaine compared to levobupivacaine alone

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Levobupivacaine
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on July 22, 2014