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OpenTrials
Completed

NCT Number: NCT02714738

Infraclavicular Block: Decreased Incidence of Tourniquet Pain, Compared to Axillary Brachial Plexus Block?

The purpose of this study is to determine whether the incidence of tourniquet pain is decreased if infraclavicular nerve block is administered, compared to axillary brachial plexus block, for surgical interventions at the level or distal to the elbow.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Anaesthesia and Intensive Care, Cork University Hospital

Cork, Co. Cork, Ireland

About this study

Pneumatic tourniquets are often used in orthopedic surgery to ensure bloodless surgical field. Besides their obvious positive effects, arterial tourniquets have some unfavorable properties. One of these is tourniquet pain, which can manifest in the presence of an otherwise adequate neuraxial or peripheral nerve block. If it develops, it is usually difficult to manage, and can be severe enough to necessitate conversion to general anaesthesia.

In the past the incidence of tourniquet pain, associated with different nerve blocks has been estimated in clinical trials for which it was a secondary outcome measure. One recent meta-analysis addressed the question: is infraclavicular block (ICB) associated with a lesser incidence of tourniquet pain compared to other brachial plexus blocks. The studies selected by this meta-analysis used different types of nerve block. However it did not address the clinically relevant question: using standard techniques for ultrasound guided brachial plexus block (USgBPB) is the infraclavicular approach associated with a lesser incidence of tourniquet pain than the axillary approach? The following nerves contribute to the perception of tourniquet pain: musculocutaneous, radial, medial cutaneous brachial (MCBN) and intercostobrachial (ICBN). The potential advantage of the ICB over the axillary brachial plexus block (ABPB) in regards to tourniquet pain comes from anatomical reasons. In the pyramid shaped infraclavicular space the cords are much closer to each other; thus the likelihood of achieving effective MCBN and ICBN block is greater. The infraclavicular route has proven to result in an equally effective, reliable and safe block of the brachial plexus, compared to the axillary approach. We hypothesize that the incidence of tourniquet pain is less with infraclavicular block compared to axillary brachial plexus block.

The aim of the study is, to compare the incidence and severity of tourniquet pain associated with ultrasound guided ICB and ABPB in patients undergoing orthopedic surgery at the level or distal to the elbow, with a tourniquet time longer than 45 minutes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-III
  • Orthopedic surgery at the level or distal to the elbow
  • Expected tourniquet time > 45 min (K-wiring not suitable)

Exclusion criteria

  • Contraindication of regional anaesthesia, patient is allergic to local anesthetics
  • Clinically significant cognitive impairment (Minimental state score < 24)
  • Chronic pain syndrome
  • Preexisting nerve damage in the operated arm (sensory or motor deficit)
  • Axillary clearance in the past
  • History of peripheral neuropathy)
  • Pregnancy

Treatment and study plan

Ultrasound guided peripheral nerve block

Procedure

Ultrasound guided peripheral nerve block

Primary outcomes

  1. Incidence of tourniquet pain

    Time frame: Intraoperative period

Secondary outcomes

  1. Onset time of tourniquet pain

    Time frame: Intraoperative period

  2. Severity of tourniquet pain

    Time frame: Intraoperative period

    Mild tourniquet pain (no need for intervention*) Moderate tourniquet pain (need for fentanyl / additional sedation*) Severe tourniquet pain (requiring GA*)

    *: based on the clinical judgement of the responsible clinician (not a member of the study team)

  3. Incidence of adverse events

    Time frame: During block placement

    Vascular puncture or paresthesia during block placement

  4. Block performance time

    Time frame: During block placement

    From commencing sterile preparation to completion of injection of local anaesthetic

  5. Block onset time

    Time frame: 30 minutes after block placement

    From completed injection of local anaesthetic until loss of cold sensation in distribution of radial, ulnar, median and musculocutaneous nerve in the hand and forearm

  6. Incidence of block failure

    Time frame: 30 minutes after block placement

    Presence of cold sensation in at least one distribute of radial, ulnar, median and musculocutaneous nerves in the hand and forearm at 30 min after completion of injection of local anaesthetic

Sponsors and collaborators

Lead sponsor

Cork University Hospital

Other

Registry information

Official study title

The Ultrasound Guided Infraclavicular Block: Decreased Incidence of Tourniquet Pain, Compared to Axillary Brachial Plexus Block?

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2016
Registry last updated
Aug 22, 2017

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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