NCT03207035

Brief Summary

We propose to compare the effects of local anaesthetic dilution on the characteristics of the ultrasound guided axillary brachial plexus block. Administration of 40ml lidocaine 1% with epinephrine will shorten the onset time of ultrasound guided axillary brachial plexus block when compared to 20 mL lidocaine 2% with epinephrine for elective upper limb surgical procedures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Status
completed

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

Study Start

First participant enrolled

October 15, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

October 18, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

May 7, 2017

Results QC Date

August 7, 2021

Last Update Submit

October 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Onset of Axillary Block

    Time taken for onset of sensory and motor axillary brachial plexus block

    1 day

Secondary Outcomes (7)

  • Duration of Sensory and Motor Block

    1 day

  • Block Performance Data- Imaging Time

    1 Hour

  • Needling Time

    1Hour

  • Performance Time

    1 Hour

  • No of Needle Pass

    1 Hour

  • +2 more secondary outcomes

Study Arms (2)

20 ml of lidocaine 2% with epinephrine

ACTIVE COMPARATOR

Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.

Procedure: Axillary brachial plexus block

40 ml 0f lidocaine 1% with epinephrine

EXPERIMENTAL

Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)

Procedure: Axillary brachial plexus block

Interventions

Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine

20 ml of lidocaine 2% with epinephrine40 ml 0f lidocaine 1% with epinephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-3
  • Patients aged \>18 years undergoing elective upper limb (forearm or hand) surgical procedures.

You may not qualify if:

  • Contraindications to regional anaesthesia
  • Hypersensitivity to amide local anaesthetics.
  • Chronic pain
  • Language barrier
  • Neuromuscular disorders or peripheral neuropathy
  • Body mass index \> 35
  • History of hepatic and renal insufficiency
  • Pregnancy
  • Cognitive or psychiatric disorder
  • Cardiac conduction abnormality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Dr Anil Ranganath
Organization
Cork University Hospital

Study Officials

  • Anil Ranganath, FCAI

    Cork University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr (Fellow in Regional Anaesthesia)

Study Record Dates

First Submitted

May 7, 2017

First Posted

July 2, 2017

Study Start

October 15, 2014

Primary Completion

March 14, 2016

Study Completion

March 14, 2016

Last Updated

October 18, 2021

Results First Posted

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share