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

NCT02714738 | Completed

• 1 other identifier: TP-ICB-ABPB
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourniquet Pain

Keywords

Brachial plexus block; Regional anesthesia; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Incidence of tourniquet pain

  Intraoperative period

Secondary Outcomes (6)

• Onset time of tourniquet pain

  Intraoperative period

• Severity of tourniquet pain

  Intraoperative period

• Incidence of adverse events

  During block placement

• Block performance time

  During block placement

• Block onset time

  30 minutes after block placement

Study Arms (2)

Infraclavicular Block

EXPERIMENTAL

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

Axillary Brachial Plexus Block

EXPERIMENTAL

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

Interventions

Ultrasound guided peripheral nerve block PROCEDURE

Ultrasound guided peripheral nerve block

Axillary Brachial Plexus Block; Infraclavicular Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Division of Anaesthesia and Intensive Care, Cork University Hospital

Cork, Co. Cork, Ireland

Location

Related Publications (5)

• 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.

  PMID: 11412159 BACKGROUND

• 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.

  PMID: 21502865 BACKGROUND

• 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.

  PMID: 17122242 BACKGROUND

• 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.

  PMID: 23986434 BACKGROUND

• 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.

  PMID: 30461447 DERIVED

Study Officials

• George Shorten, Professor

  Professor of Anaesthesia and Intensive Care Medicine, Consultant Anaesthetist, University College Cork / Cork University Hospital

  STUDY CHAIR

• Gabriella Iohom, Dr.

  Consultant Anaesthetist, Senior Lecturer, Cork University Hospital / University College Cork

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 21, 2016
• Study Start: March 1, 2016
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)