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Completed

NCT Number: NCT03957772

The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block

Patients will be randomized to one of two groups:

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. 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

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Key information

Conditions

Upper Extremity Problem

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital du Valais

Sion, 1950, Switzerland

About this study

The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups.

The first group - extrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the exterior of the fascial sheath that surrounds the nerves.

The second group - intrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the interior of the fascial sheath that surrounds the nerves.

All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.

The primary outcome is the rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound. Secondary outcomes are: rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound, bedside spirometry before the supraclavicular block, 30 minutes after the block and 2 hours after surgery, rate of successful block 30 minutes after the block , duration of sensory and motor block, pain scores at rest and on movement at 24 h postoperatively, cumulative postoperative opioid consumption at 24 hours postoperatively and patient satisfaction with overall anesthetic management.

These outcomes are further defined in the section below.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Extrafascial injection

Procedure

Extrafascial injection of local anaesthetic under ultrasound guidance

Intrafascial injection

Procedure

Intrafascial injection of local anaesthetic under ultrasound guidance

Primary outcomes

  1. Hemidiaphragmatic paresis 30 minutes after the block

    Time frame: 30 minutes after the block

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

Secondary outcomes

  1. Hemidiaphragmatic paresis 2 hours after surgery

    Time frame: 2 hours after surgery

    Rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound

  2. Bedside spirometry before the block (baseline)

    Time frame: 30 minutes before the block

    Bedside spirometry before the supraclavicular block

  3. Bedside spirometry after 30 minutes after the block

    Time frame: 30 minutes after the supraclavicular block

    Bedside spirometry after the supraclavicular block

  4. Bedside spirometry 2 hours after surgery

    Time frame: 2 hours after surgery

    Bedside spirometry 2 hours after surgery

  5. Rate of successful block 30 minutes after the block

    Time frame: 30 minutes after the block

    Presence of a surgical block according to a validated composite scale

  6. Block-related side effects

    Time frame: 24 h postoperatively

    paresthesia, dyspnea, Horner's syndrome, hoarseness, hematoma, infection

  7. Pain during block procedure

    Time frame: During block procedure

    Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain)

  8. Pain at rest and on movement

    Time frame: 24 h postoperatively

    Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain)

  9. Postoperative opioid consumption

    Time frame: 24 hours postoperatively

    Cumulative postoperative opioid consumption

  10. Patient satisfaction with overall anesthetic management

    Time frame: 24 hours postoperatively

    numeric rating scale, 0-10)

Sponsors and collaborators

Lead sponsor

Hôpital du Valais

Other

Collaborators

  • University of Lausanne Hospitals

Registry information

Official study title

The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block: a Randomized Controlled, Single-blinded Trial

Acronym: SUPRA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 21, 2019
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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