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Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients

Influence of Anesthetic Volume on Comfort Score During US-SCB Placement in Elderly Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01624103
Acronym
US-SCB
Enrollment
50
Registered
2012-06-20
Start date
2012-11-30
Completion date
2015-11-30
Last updated
2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arm Injuries, Wounds and Injuries

Keywords

Arm Injuries, Wounds and Injuries, Lidocaine, Levobupivacaine, Bupivacaine, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs

Brief 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. 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.

Interventions

PROCEDUREUpper limb surgery

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.

Sponsors

Šarić, Jadranka Pavičić, M.D.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comfort ScoreUp to average 20 minAn 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).

Secondary

MeasureTime frameDescription
Block Placement TimeUp to average 20 minutesBlock placement time was measured as the time elapsing between needle insertion and to last removal of the needle from the patient's neck.

Countries

Croatia

Contacts

Primary ContactJadranka Pavičić Šarić
jadranka.pavicic-saric@st.t-com.hr+385994888262
Backup ContactJelena Zenko
jelena.zenko@gmail.com+385994888756

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026