We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Jasminka Persec, MD, PhD, University Hospital Dubrava.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739270
First Posted: December 3, 2012
Last Update Posted: July 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jasminka Persec, MD, PhD, University Hospital Dubrava
  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 (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 Jasminka Persec, MD, PhD, University Hospital Dubrava:

Primary Outcome Measures:
  • duration of analgesia [ Time Frame: 24 hour postoperatively ]
    Duration of analgesia after supraclavicular block


Secondary Outcome Measures:
  • postoperative analgesic consumption [ Time Frame: 24 hour ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: November 25, 2012
First Posted: December 3, 2012
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Jasminka Persec, MD, PhD, University Hospital Dubrava:
analgesia
regional anesthesia
surgery
duration of analgesia
dexamethasone added to levobupivacaine compared to levobupivacaine alone

Additional relevant MeSH terms:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Levobupivacaine
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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