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

NCT ID: NCT02714738

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-05-09

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound guided peripheral nerve block

Intervention Type: PROCEDURE

Ultrasound guided peripheral nerve block

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.

Group Type: EXPERIMENTAL

Ultrasound guided peripheral nerve block

Intervention Type: PROCEDURE

Ultrasound guided peripheral nerve block

Interventions

Ultrasound guided peripheral nerve block

Ultrasound guided peripheral nerve block

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cork University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. David Brenner

Principial Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Shorten, Professor

Role: STUDY_CHAIR

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

Gabriella Iohom, Dr.

Role: STUDY_DIRECTOR

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

Locations

Division of Anaesthesia and Intensive Care, Cork University Hospital

Cork, Co. Cork, Ireland

Countries

Ireland

References

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.

Reference Type: BACKGROUND

PMID: 11412159 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21502865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17122242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23986434 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30461447 (View on PubMed)

Other Identifiers

TP-ICB-ABPB

Identifier Type: -

Identifier Source: org_study_id