A Randomised Trial Comparing Supraclavicular Block vs Supraclavicular and Pecs II Block in Arteriovenous Grafting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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This study evaluates the addition of Pecs II block to ultrasound-guided supraclavicular brachial plexus block in patients undergoing arteriovenous graft creation surgery. Participants will be randomised into two equal groups, one receiving supraclavicular and pecs II blocks, the other receiving supraclavicular block and sham block (Grade 1).

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Detailed Description

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Regional anaesthesia (RA) for arteriovenous grafting surgery has advantages of avoiding risks of general anaesthesia (GA) in this group of patients with significant co-morbidities, and beneficial vasodilatation, which may prevent early fistula thrombosis. Hence, RA is preferable to GA for this surgery.

Brachial plexus blocks (BPB) are the most commonly employed RA technique to anaesthetise the upper limb for this surgery. According to the results of a recent 2-year retrospective audit in our centre, ultrasound-guided supraclavicular BPB are the most popular RA technique for this surgery. Anatomically, the T1 and T2 dermatomes are often missed by the supraclavicular BPB. This means that the upper medial arm and axilla (sites involved in brachiobasilic and brachioaxillary arteriovenous grafting) may not be adequately anaesthetised, mandating intraoperative local anaesthetic supplementation by the surgeon. This may affect patients' and surgeons' acceptance of, and satisfaction with the RA technique. The ultrasound-guided Pecs II block, described by Blanco et al, seems to address this problem, as the intercostal T1-6, intercostobrachialis, long thoracic nerves and nerve to serratus anterior are targeted by this block.

Conditions

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Arteriovenous Fistula Arteriovenous Graft Kidney Failure, Chronic Renal Failure, End-stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Combined (C)

Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.

Group Type EXPERIMENTAL

Supraclavicular

Intervention Type PROCEDURE

Ultrasound-guided supraclavicular brachial plexus block

Pecs II block

Intervention Type PROCEDURE

Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior

Ropivacaine 0.5% 20ml

Intervention Type DRUG

Local anaesthetic solution administered for supraclavicular block

Ropivacaine 0.5% 10ml

Intervention Type DRUG

Local anaesthetic solution administered for pecs II block

Supraclavicular (S)

Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)

Group Type ACTIVE_COMPARATOR

Supraclavicular

Intervention Type PROCEDURE

Ultrasound-guided supraclavicular brachial plexus block

Sham block (Grade 1)

Intervention Type PROCEDURE

Sham block -- with skin preparation, ultrasound scanning of pecs II block area, but no actual needle injection

Ropivacaine 0.5% 20ml

Intervention Type DRUG

Local anaesthetic solution administered for supraclavicular block

Interventions

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Supraclavicular

Ultrasound-guided supraclavicular brachial plexus block

Intervention Type PROCEDURE

Pecs II block

Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior

Intervention Type PROCEDURE

Sham block (Grade 1)

Sham block -- with skin preparation, ultrasound scanning of pecs II block area, but no actual needle injection

Intervention Type PROCEDURE

Ropivacaine 0.5% 20ml

Local anaesthetic solution administered for supraclavicular block

Intervention Type DRUG

Ropivacaine 0.5% 10ml

Local anaesthetic solution administered for pecs II block

Intervention Type DRUG

Other Intervention Names

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Naropin Naropin

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for arteriovenous grafting under regional anaesthesia in Changi General Hospital
* American Society of Anaesthesiologists (ASA) physical status 3 to 4
* Elective or emergency surgery

Exclusion Criteria

* Patients unable to give consent, unable to communicate or cooperate with simple instructions
* Patients with regular consumption of strong opioids (eg. morphine, oxycodone) or steroids
* Patients with allergy or contraindications to local anaesthetics or any of the drugs included in this study
* Patients with pre-existing upper limb neurological deficits
* Patients who refuse or are unsuitable for regional anaesthesia (eg. severely coagulopathic)

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No