Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients (US-SCB)

Šarić, Jadranka Pavičić, M.D.

Status: Unknown

Conditions: Arm Injuries; Wounds and Injuries

Treatments: Procedure: Upper limb surgery

Study type: Interventional

Identifiers

NCT01624103

2012-000261-21

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Elderly (32 mL LA volume)

Experimental group

Description:

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).

Treatment:

Procedure: Upper limb surgery

Procedure: Upper limb surgery

Elderly (20 ml LA volume)

Experimental group

Description:

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).

Treatment:

Procedure: Upper limb surgery

Procedure: Upper limb surgery