Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia
July 28, 2015 updated by: Jasminka Persec, MD, PhD, University Hospital Dubrava
Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia After Supraclavicular Brachial Plexus Blockade
Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zagreb, Croatia, 10000
- Clinical Hospital Dubrava
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: dexamethasone with levobupivacaine
25ml 0.5% levobupivacaine plus 4mg Dexamethasone are given for supraclavicular brachial plexus block for upper extremity surgery
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ACTIVE_COMPARATOR: levobupivacaine
25ml 0.5% levobupivacaine plus 1ml 0.9% saline are given for supraclavicular brachial plexus block for upper extremity surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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duration of analgesia
Time Frame: 24 hour postoperatively
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Duration of analgesia after supraclavicular block
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24 hour postoperatively
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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postoperative analgesic consumption
Time Frame: 24 hour
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24 hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ino Husedzinovic, Professor, Clinical Hospital Dubrava, Head of Anesthesiology, Resuscitation and Intensive Care Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1097/AAP.0b013e3181e85eb9.
- Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
- Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
January 1, 2013
Study Registration Dates
First Submitted
November 25, 2012
First Submitted That Met QC Criteria
November 30, 2012
First Posted (ESTIMATE)
December 3, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
July 29, 2015
Last Update Submitted That Met QC Criteria
July 28, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.