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

Not Applicable

Completed

• Conditions: Arteriovenous Graft; Arteriovenous Fistula; Kidney Failure, Chronic; Renal Failure, End-stage
• Interventions: Procedure: Supraclavicular; Procedure: Pecs II block; Procedure: Sham block (Grade 1); Drug: Ropivacaine 0.5% 20ml; Drug: Ropivacaine 0.5% 10ml

• Registration Number: NCT02331030
• Lead Sponsor: Changi General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-31
• Study First Submitted QC: 2015-01-01
• Study First Posted: 2015-01-05
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined (C)	Ropivacaine 0.5% 20ml	Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
Combined (C)	Ropivacaine 0.5% 10ml	Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
Combined (C)	Pecs II block	Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
Combined (C)	Supraclavicular	Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
Supraclavicular (S)	Sham block (Grade 1)	Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)
Supraclavicular (S)	Supraclavicular	Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)
Supraclavicular (S)	Ropivacaine 0.5% 20ml	Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)

Primary Outcome Measures

Name	Time	Method
Need for intraoperative local anaesthetic supplementation by the surgeon	Intraoperative	Whether there was a need for the surgeon to infiltrate a standardised local anaesthetic drug (0.5% ropivacaine) to the operative site during surgery

Secondary Outcome Measures

Name	Time	Method
Volume of intraoperative local anaesthetic supplementation administered	Intraoperative	Total volume of local anaesthetic drug (0.5% ropivacaine) given by the surgeon
Need for additional sedation or systemic analgesia	Intraoperative	Whether there was a need for additional sedation or systemic analgesia (on top of what is specified in the protocol)
Highest pain score at Post-Anaesthesia Care Unit (PACU)	Up to 1 hour post-operatively	Highest pain score on visual analogue scale at the post-anaesthesia care unit
Time to first post-operative analgesia	Up to 24 hours post-operatively	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.
Pain score at 12h	12 hours post-operatively	Pain score on visual analogue scale 12 hours after surgery
Pain score at 24h	24 hours post-operatively	Pain score on visual analogue scale 24 hours after surgery
Patient satisfaction at 24hours	24 hours post-operatively	Patient satisfaction with the anaesthesia technique on a 5-point Likert scale 24 hours after surgery

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore