Brachial Plexus AnesthesiaNCT01739270
Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia
A study testing supraclavicular brachial plexus block in people with Brachial Plexus Anesthesia and Analgesia, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brachial Plexus Anesthesia, Analgesia
- What is being tested?
- supraclavicular brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 years or older
- ASA (American Society of Anesthesiologists) physical status I, II or III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brachial Plexus Anesthesia, Analgesia
- Being tested
- supraclavicular brachial plexus block
- Keywords
- analgesia, regional anesthesia, surgery, duration of analgesia, dexamethasone added to levobupivacaine compared to levobupivacaine alone
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraclavicular brachial plexus blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone with levobupivacaine | Active comparator | 25ml 0.5% levobupivacaine plus 4mg Dexamethasone are given for supraclavicular brachial plexus block for upper extremity surgery Receives: Procedure: supraclavicular brachial plexus block |
| levobupivacaine | Active comparator | 25ml 0.5% levobupivacaine plus 1ml 0.9% saline are given for supraclavicular brachial plexus block for upper extremity surgery Receives: Procedure: supraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of analgesia
Duration of analgesia after supraclavicular block
Measured: 24 hour postoperatively
Secondary outcomes (1)
postoperative analgesic consumption
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasminka Persec, MD, PhD, University Hospital Dubrava
- Investigators
- Ino Husedzinovic, Professor, Study chair, Clinical Hospital Dubrava, Head of Anesthesiology, Resuscitation and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739270
- Sponsor's protocol ID
- 0911
- Status last verified
- Jul 2015
- First submitted
- 25 Nov 2012
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20814282Vieira 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.
PubMed 20009936Kim 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.
PubMed 22379567
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia After Supraclavicular Brachial Plexus Blockade
- ClinicalTrials.gov ID
- NCT01739270
- Acronym / sponsor ID
- 0911
- Conditions
- Brachial Plexus Anesthesia, Analgesia
- Keywords
- analgesia, regional anesthesia, surgery, duration of analgesia, dexamethasone added to levobupivacaine compared to levobupivacaine alone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone with levobupivacaine | Active comparator | Procedure: supraclavicular brachial plexus block25ml 0.5% levobupivacaine plus 4mg Dexamethasone are given for supraclavicular brachial plexus block for upper extremity surgery |
| levobupivacaine | Active comparator | Procedure: supraclavicular brachial plexus block25ml 0.5% levobupivacaine plus 1ml 0.9% saline are given for supraclavicular brachial plexus block for upper extremity surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18 years or older
- ASA (American Society of Anesthesiologists) physical status I, II or III
Key exclusion criteria (7 listed)
- refusal of the patients to give informed consent
- preexisting coagulation disorders
- local infection at the site of the block
- neuropathy
- drug or alcohol abusers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supraclavicular brachial plexus block | Procedure or surgery | dexamethasone with levobupivacaine, levobupivacaine |
Primary outcome
duration of analgesia
Time frame: 24 hour postoperatively
Duration of analgesia after supraclavicular block
1 secondary outcome
postoperative analgesic consumption
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Results publication: PubMed 20814282Parrington 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.
- Results publication: PubMed 20009936Vieira 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.
- Results publication: PubMed 22379567Kim 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.
Related trials for Brachial Plexus Anesthesia
Recruiting
Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: Selective Trunk Block vs Supraclavicular Brachial Plexus Block
Musculoskeletal Diseases or Conditions
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Perfusion Index in Monitoring Recovery From Brachial Plexus Block After Forearm Surgery
Forearm Surgeries, Brachial Plexus Blockade
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ino Husedzinovic, Professor study chair
Clinical Hospital Dubrava, Head of Anesthesiology, Resuscitation and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supraclavicular brachial plexus block in people with Brachial Plexus Anesthesia and Analgesia, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of analgesia (time frame: 24 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739270, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.