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Tourniquet PainNCT02714738

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

A study testing Ultrasound guided peripheral nerve block in people with Tourniquet Pain, run by Cork University Hospital at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tourniquet Pain
What is being tested?
Ultrasound guided peripheral nerve block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteIreland
Study dates
Mar 2016to 9 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Division of Anaesthesia and Intensive Care, Cork University Hospital

    Cork, Co. Cork

Other trials in Ireland

About this study

Official title: The Ultrasound Guided 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.

Read the 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.

Conditions
Tourniquet Pain
Being tested
Ultrasound guided peripheral nerve block
Keywords
Brachial plexus block, Regional anesthesia, Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided peripheral nerve blockProcedure or surgery

    Ultrasound guided peripheral nerve block

Study groups in NCT02714738
Study groupRoleWhat they receive
Infraclavicular BlockExperimentalThe 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.
Receives: Procedure: Ultrasound guided peripheral nerve block
Axillary Brachial Plexus BlockExperimentalThe 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.
Receives: Procedure: Ultrasound guided peripheral nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of tourniquet pain

    Measured: Intraoperative period

Secondary outcomes (6)

  1. Onset time of tourniquet pain

    Measured: Intraoperative period

  2. Severity of tourniquet pain

    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)

    Measured: Intraoperative period

  3. Incidence of adverse events

    Vascular puncture or paresthesia during block placement

    Measured: During block placement

  4. Block performance time

    From commencing sterile preparation to completion of injection of local anaesthetic

    Measured: During block placement

  5. Block onset time

    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

    Measured: 30 minutes after block placement

  6. Incidence of block failure

    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

    Measured: 30 minutes after block placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion9 May 2017
  4. Study completion9 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02714738
Sponsor's protocol ID
TP-ICB-ABPB
Status last verified
Aug 2017
First submitted
16 Mar 2016
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.

    PubMed 11412159

  • Estebe JP, Davies JM, Richebe P. The pneumatic tourniquet: mechanical, ischaemia-reperfusion and systemic effects. Eur J Anaesthesiol. 2011 Jun;28(6):404-11. doi: 10.1097/EJA.0b013e328346d5a9.

    PubMed 21502865

  • Sauter AR, Smith HJ, Stubhaug A, Dodgson MS, Klaastad O. Use of magnetic resonance imaging to define the anatomical location closest to all three cords of the infraclavicular brachial plexus. Anesth Analg. 2006 Dec;103(6):1574-6. doi: 10.1213/01.ane.0000242529.96675.fd.

    PubMed 17122242

  • Chin KJ, Alakkad H, Adhikary SD, Singh M. Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. Cochrane Database Syst Rev. 2013 Aug 28;2013(8):CD005487. doi: 10.1002/14651858.CD005487.pub3.

    PubMed 23986434

  • Brenner D, Iohom G, Mahon P, Shorten G. Efficacy of axillary versus infraclavicular brachial plexus block in preventing tourniquet pain: A randomised trial. Eur J Anaesthesiol. 2019 Jan;36(1):48-54. doi: 10.1097/EJA.0000000000000928.

    PubMed 30461447

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided peripheral nerve block in people with Tourniquet Pain, run by Cork University Hospital at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of tourniquet pain (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714738, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.

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