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Clinical Trials/NCT01624103
NCT01624103
Unknown
Not Applicable

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

Šarić, Jadranka Pavičić, M.D.1 site in 1 country50 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arm Injuries
Sponsor
Šarić, Jadranka Pavičić, M.D.
Enrollment
50
Locations
1
Primary Endpoint
Comfort Score
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
November 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Šarić, Jadranka Pavičić, M.D.
Responsible Party
Principal Investigator
Principal Investigator

Jadranka Pavičić Šarić

Principal Investigator

Clinical Hospital Merkur

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Block Placement Time(Up to average 20 minutes)

Study Sites (1)

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