NCT03957772

Brief Summary

Patients will be randomized to one of two groups:

  1. 1.Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath that surrounds the nerves
  2. 2.Intrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the interior of the fascial sheath that surrounds the nerves

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

May 17, 2019

Last Update Submit

May 17, 2021

Conditions

Upper Extremity Problem

Keywords

upper extremity surgery

Outcome Measures

Primary Outcomes (1)

  • Hemidiaphragmatic paresis 30 minutes after the block

    Rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound

    30 minutes after the block

Secondary Outcomes (10)

  • Hemidiaphragmatic paresis 2 hours after surgery

    2 hours after surgery

  • Bedside spirometry before the block (baseline)

    30 minutes before the block

  • Bedside spirometry after 30 minutes after the block

    30 minutes after the supraclavicular block

  • Bedside spirometry 2 hours after surgery

    2 hours after surgery

  • Rate of successful block 30 minutes after the block

    30 minutes after the block

  • +5 more secondary outcomes

Study Arms (2)

Extrafascial injection

ACTIVE COMPARATOR

Extrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic

Procedure: Extrafascial injection

Intrafascial injection

EXPERIMENTAL

Intrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic

Procedure: Intrafascial injection

Interventions

Extrafascial injectionPROCEDURE

Extrafascial injection of local anaesthetic under ultrasound guidance

Extrafascial injection
Intrafascial injectionPROCEDURE

Intrafascial injection of local anaesthetic under ultrasound guidance

Intrafascial injection

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing forearm or hand surgery under locoregional anesthesia
  • ASA physical status I-III

You may not qualify if:

  • Patient refusal
  • ASA physical status IV
  • Severe pre-existing lung disease
  • Patient unwilling or unable to perform incentive spirometry
  • Local anesthetic intolerance or allergy
  • Neurological deficit or neuropathy of the arm
  • Coagulopathy contraindicating locoregional anesthesia
  • Malignancy or infection in the area above the clavicle
  • Pregnancy
  • Inability to understand the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital du Valais

Sion, 1950, Switzerland

Location

Related Publications (1)

  • Grape S, Kirkham K, Zemirline N, Bikfalvi A, Albrecht E. Impact of an extrafascial versus intrafascial injection for supraclavicular brachial plexus block on respiratory function: a randomized, controlled, double-blind trial. Reg Anesth Pain Med. 2022 Oct;47(10):604-609. doi: 10.1136/rapm-2022-103634. Epub 2022 Jul 1.

    PMID: 35777931DERIVED

Study Officials

  • Sina Grape, MD

    Hôpital du Valais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The participants and all care providers will be blinded to the patient assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 21, 2019

Study Start

January 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

no sharing of any IPD

Locations

CH(1)