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

Primary Purpose

Arm Injuries, Wounds and Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Upper limb surgery
Upper limb surgery
Sponsored by
Šarić, Jadranka Pavičić, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arm Injuries focused on measuring Arm Injuries, Wounds and Injuries, Lidocaine, Levobupivacaine, Bupivacaine, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Hospital MerkurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Elderly (32 mL LA volume)

Elderly (20 ml LA volume)

Arm 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).

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).

Outcomes

Primary Outcome Measures

Comfort Score
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 Outcome Measures

Block Placement Time
Block placement time was measured as the time elapsing between needle insertion and to last removal of the needle from the patient's neck.

Full Information

First Posted
June 16, 2012
Last Updated
March 2, 2015
Sponsor
Šarić, Jadranka Pavičić, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01624103
Brief Title
Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients
Acronym
US-SCB
Official Title
Influence of Anesthetic Volume on Comfort Score During US-SCB Placement in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Šarić, Jadranka Pavičić, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Injuries, Wounds and Injuries
Keywords
Arm Injuries, Wounds and Injuries, Lidocaine, Levobupivacaine, Bupivacaine, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elderly (32 mL LA volume)
Arm Type
Experimental
Arm 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).
Arm Title
Elderly (20 ml LA volume)
Arm Type
Experimental
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
Upper limb surgery
Other Intervention Name(s)
Levobupivacaine, Lidocaine, Chirocaine, Xilocaine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Upper limb surgery
Other Intervention Name(s)
Levobupivacaine, Lidocaine, Chirocaine, Xilocaine
Intervention Description
Elderly patients undergoing upper limb surgery received 32 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.
Primary Outcome Measure Information:
Title
Comfort Score
Description
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).
Time Frame
Up to average 20 min
Secondary Outcome Measure Information:
Title
Block Placement Time
Description
Block placement time was measured as the time elapsing between needle insertion and to last removal of the needle from the patient's neck.
Time Frame
Up to average 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jadranka Pavičić Šarić
Phone
+385994888262
Email
jadranka.pavicic-saric@st.t-com.hr
First Name & Middle Initial & Last Name or Official Title & Degree
Jelena Zenko
Phone
+385994888756
Email
jelena.zenko@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matea Bogdanović Dvorščak, MD
Organizational Affiliation
Clinical Hospital Merkur, Department of Anesthesiology and Intensive Care
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Hospital Merkur
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jadranka Pavičić Šarić

12. IPD Sharing Statement

Citations:
PubMed Identifier
20299995
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.
Results Reference
background
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
Results Reference
background

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

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