- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01624103
Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients (US-SCB)
March 2, 2015 updated by: Jadranka Pavičić Šarić, Šarić, Jadranka Pavičić, M.D.
Influence of Anesthetic Volume on Comfort Score During US-SCB Placement in Elderly Patients
Results from our preliminary study accepted as e-poster presentation on ESRA (Bordeaux, September 2012.)
showed significant difference in Comfort Score during Ultrasound Guided Supraclavicular Brachial Plexus block (US-SCB) between young and elderly population.
However, it is unknown whether the difference in Comfort score (1) was associated with reduction of local anesthetic (LA) volume in elderly or it is attributed to elderly population by itself.
The aim of the study is to compare the Comfort score during US-SCB placement in elderly patients undergoing upper limb surgery performed with two different volumes of local anesthetics (20 ml vs 32 ml).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Involutional changes of brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial plexus at the first rib, allowed a 35% reduction of LA volume for an effective US-SCB in comparison with the younger patients (2).
Ultrasound-guided regional anesthesia becomes an increasingly popular technique and its performance must be as comfortable as possible.
Therefore, Comfort score during block placement is extremely important.
Comfort Score is consisted of maximum pain intensity (VAS), the satisfaction of the patient and the number of unpleasant events declared by the patients.
It is calculated as the sum of each criterion, which was attributed a value of 0 or 1: VAS(<or=30/100, 1; >30/100, 0), number of unpleasant events (0, 1; >or=1, 0) and satisfaction (satisfied or very satisfied, 1; acceptable or unsatisfied, 0).
Comfort score of 3 or 2 is considered as comfortable while score 1 or 0 as uncomfortable block placement.
Study Type
Interventional
Enrollment (Anticipated)
50
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 Contact
- Name: Jadranka Pavičić Šarić
- Phone Number: +385994888262
- Email: jadranka.pavicic-saric@st.t-com.hr
Study Contact Backup
- Name: Jelena Zenko
- Phone Number: +385994888756
- Email: jelena.zenko@gmail.com
Study Locations
-
-
-
Zagreb, Croatia, 10000
- Recruiting
- Clinical Hospital Merkur
-
Principal Investigator:
- Jadranka Pavičić Šarić
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age over 65 years (Elderly group)
- upper limb surgery
Exclusion Criteria:
- refusal of regional anesthesia
- any neurologic or neuromuscular disease
- clinical signs of cutaneous infection at the site of needle insertion
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elderly (32 mL LA volume)
Population over age of 65 undergoing upper limb surgery using US-SCB receiving 32 ml of LA (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine).
|
Elderly patients undergoing upper limb surgery received 20 ml of LA volume (50:50 mixture of levobupivacaine 0.5% and lidocaine 2%) for US-SCB.
An independent observer unaware of the LA volume recorded maximal pain intensity resulting from block placements, questioned the patients about possible unpleasant events linked to the performance of US-SCB and assessed patient's satisfaction.
Other Names:
Elderly patients undergoing upper limb surgery received 32 ml of LA volume (50:50 mixture of levobupivacaine 0.5% and lidocaine 2%) for US-SCB.
An independent observer unaware of the LA volume recorded maximal pain intensity resulting from block placements, questioned the patients about possible unpleasant events linked to the performance of US-SCB and assessed patient's satisfaction.
Other Names:
|
Experimental: Elderly (20 ml LA volume)
Population over age of 65 undergoing upper limb surgery using US-SCB receiving 20 ml of LA (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine).
|
Elderly patients undergoing upper limb surgery received 20 ml of LA volume (50:50 mixture of levobupivacaine 0.5% and lidocaine 2%) for US-SCB.
An independent observer unaware of the LA volume recorded maximal pain intensity resulting from block placements, questioned the patients about possible unpleasant events linked to the performance of US-SCB and assessed patient's satisfaction.
Other Names:
Elderly patients undergoing upper limb surgery received 32 ml of LA volume (50:50 mixture of levobupivacaine 0.5% and lidocaine 2%) for US-SCB.
An independent observer unaware of the LA volume recorded maximal pain intensity resulting from block placements, questioned the patients about possible unpleasant events linked to the performance of US-SCB and assessed patient's satisfaction.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort Score
Time Frame: Up to average 20 min
|
An independent observer unaware of the administered LA volume assessed Comfort score by evaluating maximal pain intensity resulting from block placement using a 100-mm visual analogue scale (VAS: 0, no pain-100, maximum or worst imaginable) as well as by recording any unpleasant event during block placement and by recording patient satisfaction using a four-point scale (unsatisfied, acceptable, satisfied and very satisfied).
|
Up to average 20 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Block Placement Time
Time Frame: Up to average 20 minutes
|
Block placement time was measured as the time elapsing between needle insertion and to last removal of the needle from the patient's neck.
|
Up to average 20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Matea Bogdanović Dvorščak, MD, Clinical Hospital Merkur, Department of Anesthesiology and Intensive Care
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
- Bloc S, Mercadal L, Garnier T, Komly B, Leclerc P, Morel B, Ecoffey C, Dhonneur G. Comfort of the patient during axillary blocks placement: a randomized comparison of the neurostimulation and the ultrasound guidance techniques. Eur J Anaesthesiol. 2010 Jul;27(7):628-33. doi: 10.1097/EJA.0b013e328333fc0a.
- Tomulic K, Pavicic Saric J, Acan I.Effect of age on anaesthetic volume for ultrasound guided supraclavicular brachial plexus block: 8AP2-8 European Journal of Anaesthesiology 28:113,2011
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
November 1, 2012
Primary Completion (Anticipated)
November 1, 2015
Study Completion (Anticipated)
November 1, 2015
Study Registration Dates
First Submitted
June 16, 2012
First Submitted That Met QC Criteria
June 19, 2012
First Posted (Estimate)
June 20, 2012
Study Record Updates
Last Update Posted (Estimate)
March 3, 2015
Last Update Submitted That Met QC Criteria
March 2, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Arm Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Levobupivacaine
Other Study ID Numbers
- 2012-000261-21
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.
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