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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Šarić, Jadranka Pavičić, M.D.
Sponsor:
Information provided by (Responsible Party):
Jadranka Pavičić Šarić, Clinical Hospital Merkur
ClinicalTrials.gov Identifier:
NCT01624103
First received: June 16, 2012
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention
Arm Injuries
Wounds and Injuries
Procedure: Upper limb surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Anesthetic Volume on Comfort Score During US-SCB Placement in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Šarić, Jadranka Pavičić, M.D.:

Primary Outcome Measures:
  • Comfort Score [ Time Frame: Up to average 20 min ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to average 20 minutes ] [ Designated as safety issue: Yes ]
    Block placement time was measured as the time elapsing between needle insertion and to last removal of the needle from the patient's neck.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly (32 mL LA volume)
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).
Procedure: Upper limb surgery
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.
Other Names:
  • Levobupivacaine
  • Lidocaine
  • Chirocaine
  • Xilocaine
Experimental: Elderly (20 ml LA volume)
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).
Procedure: Upper limb surgery
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.
Other Names:
  • Levobupivacaine
  • Lidocaine
  • Chirocaine
  • Xilocaine

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624103

Contacts
Contact: Jadranka Pavičić Šarić +385994888262 jadranka.pavicic-saric@st.t-com.hr
Contact: Jelena Zenko +385994888756 jelena.zenko@gmail.com

Locations
Croatia
Clinical Hospital Merkur Recruiting
Zagreb, Croatia, 10000
Principal Investigator: Jadranka Pavičić Šarić         
Sponsors and Collaborators
Šarić, Jadranka Pavičić, M.D.
Investigators
Study Chair: Matea Bogdanović Dvorščak, MD Clinical Hospital Merkur, Department of Anesthesiology and Intensive Care
  More Information

Publications:
Responsible Party: Jadranka Pavičić Šarić, Principal Investigator, Clinical Hospital Merkur
ClinicalTrials.gov Identifier: NCT01624103     History of Changes
Other Study ID Numbers: 2012-000261-21
Study First Received: June 16, 2012
Last Updated: June 26, 2013
Health Authority: Croatia: Ethics Committee

Keywords provided by Šarić, Jadranka Pavičić, M.D.:
Arm Injuries
Wounds and Injuries
Lidocaine
Levobupivacaine
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries
Anesthetics
Lidocaine
Levobupivacaine
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014