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

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.

Study Overview

• Status: Completed
• Conditions: Tourniquet Pain
• Intervention / Treatment: Procedure: Ultrasound guided peripheral nerve block

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co. Cork
    • Cork, Co. Cork, Ireland
      • Division of Anaesthesia and Intensive Care, Cork University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of tourniquet pain	Intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset time of tourniquet pain		Intraoperative period
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)	Intraoperative period
Incidence of adverse events	Vascular puncture or paresthesia during block placement	During block placement
Block performance time	From commencing sterile preparation to completion of injection of local anaesthetic	During block placement
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	30 minutes after block placement
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	30 minutes after block placement

Collaborators and Investigators

• Sponsor: Cork University Hospital
• Investigators: 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 and helpful links

General Publications

• 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. Erratum In: Anesth Analg. 2007 Mar;104(3):562.
• 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. Erratum In: Anaesthesia 2001 Aug;56(8):821. Kavanaugh R [corrected to Kavanagh R].
• 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.
• 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;(8):CD005487. doi: 10.1002/14651858.CD005487.pub3.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 9, 2017
• Study Completion (Actual): May 9, 2017

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 19, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Regional anesthesia; Brachial plexus block
• Other Study ID Numbers: TP-ICB-ABPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No