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

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ClinicalTrials.gov Identifier: NCT02714738
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. David Brenner, Cork University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tourniquet Pain Procedure: Ultrasound guided peripheral nerve block Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Ultrasound Guided Infraclavicular Block: Decreased Incidence of Tourniquet Pain, Compared to Axillary Brachial Plexus Block?
Study Start Date : March 2016
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : May 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Infraclavicular Block
The patient will be positioned supine. The operating limb may be positioned abducted or adducted by side depending on operator preference and patient factors. After standard preparation, the needle will be directed towards the target area using an in-plane, short-axis technique. Local anaesthetic (lidocaine 2% with epinephrine 1:200.000) will be injected posterior to the artery with the intention achieving the U shape, cranio-postero-caudal spread. Local anaesthetic will be deposited to the lateral and medial cords as well, if required. The total dose of the local anaesthetic will be 20-30 ml, as clinically indicated.
Procedure: Ultrasound guided peripheral nerve block
Ultrasound guided peripheral nerve block

Experimental: Axillary Brachial Plexus Block
The patient will be positioned supine with the operative upper limb extended, flexed at the elbow, rested on a pillow to expose the axilla. After standard preparation, the needle will be directed towards the target area using an in-plane, short-axis technique. All four nerves in the axillary region are being blocked. The local anesthetic (lidocaine 2% with epinephrine 1:200.000, 15-25 ml) will be divided among the four nerves as clinically indicated by the spread, but at least 3 ml applied to each nerve.
Procedure: Ultrasound guided peripheral nerve block
Ultrasound guided peripheral nerve block




Primary Outcome Measures :
  1. Incidence of tourniquet pain [ Time Frame: Intraoperative period ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714738


Locations
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Ireland
Division of Anaesthesia and Intensive Care, Cork University Hospital
Cork, Co. Cork, Ireland
Sponsors and Collaborators
Cork University Hospital
Investigators
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Study Chair: George Shorten, Professor Professor of Anaesthesia and Intensive Care Medicine, Consultant Anaesthetist, University College Cork / Cork University Hospital
Study Director: Gabriella Iohom, Dr. Consultant Anaesthetist, Senior Lecturer, Cork University Hospital / University College Cork
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. David Brenner, Principial Investigator, Cork University Hospital
ClinicalTrials.gov Identifier: NCT02714738    
Other Study ID Numbers: TP-ICB-ABPB
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. David Brenner, Cork University Hospital:
Brachial plexus block
Regional anesthesia
Ultrasound