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

Study Overview
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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).

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.

Official Title
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A Randomised Controlled Trial Comparing Ultrasound-guided Supraclavicular Brachial Plexus Block With Combined Supraclavicular and Pecs II Block in Patients Undergoing Arteriovenous Grafting Surgery

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

Intervention / Treatment
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* Procedure: Supraclavicular
* Procedure: Pecs II block
* Procedure: Sham block (Grade 1)
* Drug: Ropivacaine 0.5% 20ml
* Drug: Ropivacaine 0.5% 10ml


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined (C)<br>Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml. | Procedure: Supraclavicular<br>* Ultrasound-guided supraclavicular brachial plexus block<br>Procedure: Pecs II block<br>* Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior<br>Drug: Ropivacaine 0.5% 20ml<br>* Local anaesthetic solution administered for supraclavicular block<br>* Other names: Naropin;Drug: Ropivacaine 0.5% 10ml<br>* Local anaesthetic solution administered for pecs II block<br>* Other names: Naropin;|
| Active Comparator: Supraclavicular (S)<br>Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1) | Procedure: Supraclavicular<br>* Ultrasound-guided supraclavicular brachial plexus block<br>Procedure: Sham block (Grade 1)<br>* Sham block -- with skin preparation, ultrasound scanning of pecs II block area, but no actual needle injection<br>Drug: Ropivacaine 0.5% 20ml<br>* Local anaesthetic solution administered for supraclavicular block<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for intraoperative local anaesthetic supplementation by the surgeon | Whether there was a need for the surgeon to infiltrate a standardised local anaesthetic drug (0.5% ropivacaine) to the operative site during surgery | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of intraoperative local anaesthetic supplementation administered | Total volume of local anaesthetic drug (0.5% ropivacaine) given by the surgeon | Intraoperative | 
| Need for additional sedation or systemic analgesia | Whether there was a need for additional sedation or systemic analgesia (on top of what is specified in the protocol) | Intraoperative | 
| Highest pain score at Post-Anaesthesia Care Unit (PACU) | Highest pain score on visual analogue scale at the post-anaesthesia care unit | Up to 1 hour post-operatively | 
| Time to first post-operative analgesia | Duration of time from administration of the block(s) to when patient first requests for oral analgesia. Participants will be followed up for 24 hours after surgery. | Up to 24 hours post-operatively | 
| Pain score at 12h | Pain score on visual analogue scale 12 hours after surgery | 12 hours post-operatively | 
| Pain score at 24h | Pain score on visual analogue scale 24 hours after surgery | 24 hours post-operatively | 
| Patient satisfaction at 24hours | Patient satisfaction with the anaesthesia technique on a 5-point Likert scale 24 hours after surgery | 24 hours post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brachio-axillary, brachio-basilic, interfascial plane block, Pecs II block, supraclavicular brachial plexus block