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

Tourniquet Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714738
• Other study ID #: TP-ICB-ABPB
• Status: Completed
• Phase: N/A
• First received: March 16, 2016
• Last updated: August 19, 2017
• Start date: March 2016
• Est. completion date: May 9, 2017

Study information

• Verified date: August 2017
• Source: Cork University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tourniquet Pain

Intervention

Procedure:
• Ultrasound guided peripheral nerve block
Ultrasound guided peripheral nerve block

Locations

Country	Name	City	State
Ireland	Division of Anaesthesia and Intensive Care, Cork University Hospital	Cork	Co. Cork

Sponsors (1)

Lead Sponsor	Collaborator
Cork University Hospital

Country where clinical trial is conducted

Ireland, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. Review. Erratum in: Anaesthesia 2001 Aug;56(8):821. Kavanaugh R [corrected to Kavanagh R]. — View Citation

Sauter AR, Smith HJ, Stubhaug A, Dodgson MS, Klaastad Ø. 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. Erratum in: Anesth Analg. 2007 Mar;104(3):562. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of tourniquet pain		Intraoperative period
Secondary	Onset time of tourniquet pain		Intraoperative period
Secondary	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
Secondary	Incidence of adverse events	Vascular puncture or paresthesia during block placement	During block placement
Secondary	Block performance time	From commencing sterile preparation to completion of injection of local anaesthetic	During block placement
Secondary	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
Secondary	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