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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Šarić, Jadranka Pavičić, M.D.

Current 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Šarić, Jadranka Pavičić, M.D.

Dates:
Date Received: June 16, 2012
Date Started: November 2012
Date Completion: November 2015
Last Updated: March 2, 2015
Last Verified: March 2015