Arm InjuriesUS-SCBNCT01624103
Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients
A study testing Upper limb surgery in people with Arm Injuries and Wounds and Injuries, run by Šarić, Jadranka Pavičić, M.D. at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Arm Injuries, Wounds and Injuries
- What is being tested?
- Upper limb surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- Nov 2012to Nov 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age over 65 years (Elderly group)
- upper limb surgery
Who cannot join
- refusal of regional anesthesia
- any neurologic or neuromuscular disease
- clinical signs of cutaneous infection at the site of needle insertion
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Merkur
Zagreb, City of Zagreb, 10000
Jadranka Pavičić Šarić
About this study
Official title: 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).
Read the 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.
- Conditions
- Arm Injuries, Wounds and Injuries
- Being tested
- Upper limb surgery
- Keywords
- Arm Injuries, Wounds and Injuries, Lidocaine, Levobupivacaine, Bupivacaine, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs
- Medical subject headings
- Arm Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb surgeryProcedure or surgery
Also called Levobupivacaine, Lidocaine, Chirocaine, Xilocaine
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.
Upper limb surgeryProcedure or surgery
Also called Levobupivacaine, Lidocaine, Chirocaine, Xilocaine
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.
| Study group | Role | What they receive |
|---|---|---|
| Elderly (32 mL LA volume) | Experimental | 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). Receives: Procedure: Upper limb surgery |
| Elderly (20 ml LA volume) | Experimental | 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). Receives: Procedure: Upper limb surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort Score
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).
Measured: Up to average 20 min
Secondary outcomes (1)
Block Placement Time
Block placement time was measured as the time elapsing between needle insertion and to last removal of the needle from the patient's neck.
Measured: Up to average 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arm InjuriesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Šarić, Jadranka Pavičić, M.D.
- Responsible party
- Principal investigator, Jadranka Pavičić Šarić, Clinical Hospital Merkur
- Investigators
- Matea Bogdanović Dvorščak, MD, Study chair, Clinical Hospital Merkur, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624103
- Sponsor's protocol ID
- 2012-000261-21
- Acronym
- US-SCB
- Status last verified
- Mar 2015
- First submitted
- 16 Jun 2012
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20299995Tomulic 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 at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Anesthetic Volume on Comfort Score During US-SCB Placement in Elderly Patients
- ClinicalTrials.gov ID
- NCT01624103
- Acronym / sponsor ID
- US-SCB / 2012-000261-21
- Conditions
- Arm Injuries, Wounds and Injuries
- Keywords
- Arm Injuries, Wounds and Injuries, Lidocaine, Levobupivacaine, Bupivacaine, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Šarić, Jadranka Pavičić, M.D.
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 20 Jun 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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly (32 mL LA volume) | Experimental | Procedure: Upper limb surgeryPopulation 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 (20 ml LA volume) | Experimental | Procedure: Upper limb surgeryPopulation 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age over 65 years (Elderly group)
- upper limb surgery
Key exclusion criteria (3 listed)
- refusal of regional anesthesia
- any neurologic or neuromuscular disease
- clinical signs of cutaneous infection at the site of needle insertion
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 |
|---|---|---|
| Upper limb surgeryAlso: Levobupivacaine, Lidocaine, Chirocaine, XilocaineElderly 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. | Procedure or surgery | Elderly (20 ml LA volume) |
| Upper limb surgeryAlso: Levobupivacaine, Lidocaine, Chirocaine, XilocaineElderly 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. | Procedure or surgery | Elderly (32 mL LA volume) |
Primary outcome
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).
1 secondary outcome
Block Placement Time
Time frame: Up to average 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Background: PubMed 20299995Bloc 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.
- BackgroundTomulic 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
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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.
Matea Bogdanović Dvorščak, MD study chair
Clinical Hospital Merkur, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb surgery in people with Arm Injuries and Wounds and Injuries, run by Šarić, Jadranka Pavičić, M.D. 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 3 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 3 Mar 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?
Contact Jadranka Pavičić Šarić (+385994888262, jadranka.pavicic-saric@st.t-com.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort Score (time frame: Up to average 20 min). 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 NCT01624103, which also lists 2 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 3 Mar 2015.