Clinical trial NCT01624103: Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients
Official title: Influence of Anesthetic Volume on Comfort Score During US-SCB Placement in Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arm Injuries
Wounds and Injuries
Keywords: Arm Injuries
Wounds and Injuries
Lidocaine
Levobupivacaine
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Lead sponsor: Šarić, Jadranka Pavičić, M.D.
Sponsor class: INDIV
First posted: 2012-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comfort Score
timeFrame: Up to average 20 min
Secondary outcomes:
measure: Block Placement Time
timeFrame: Up to average 20 minutes
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Merkur
Study officials:
affiliation: Clinical Hospital Merkur, Department of Anesthesiology and Intensive Care
name: Matea Bogdanović Dvorščak, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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