NCT01624103

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

June 16, 2012

Last Update Submit

March 2, 2015

Conditions

Arm InjuriesWounds and Injuries

Keywords

Arm InjuriesWounds and InjuriesLidocaineLevobupivacaineBupivacaineAnestheticsCentral Nervous System DepressantsPhysiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

  • 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).

    Up to average 20 min

Secondary Outcomes (1)

  • Block Placement Time

    Up to average 20 minutes

Study Arms (2)

Elderly (32 mL LA volume)

EXPERIMENTAL

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 (20 ml LA volume)

EXPERIMENTAL

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

Interventions

Upper limb surgeryPROCEDURE

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.

Also known as: Levobupivacaine, Lidocaine, Chirocaine, Xilocaine
Elderly (20 ml LA volume)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age over 65 years (Elderly group)
  • upper limb surgery

You may not qualify if:

  • refusal of regional anesthesia
  • any neurologic or neuromuscular disease
  • clinical signs of cutaneous infection at the site of needle insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital Merkur

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20299995BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Arm InjuriesWounds and Injuries

Interventions

LevobupivacaineLidocaine

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Officials

  • Matea Bogdanović Dvorščak, MD

    Clinical Hospital Merkur, Department of Anesthesiology and Intensive Care

    STUDY CHAIR

Central Study Contacts

Jadranka Pavičić Šarić

CONTACT

+385994888262jadranka.pavicic-saric@st.t-com.hr

Jelena Zenko

CONTACT

+385994888756jelena.zenko@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2012

First Posted

June 20, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

CR(1)