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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02331030
Enrollment
36
Registered
2015-01-05
Start date
2014-12-31
Completion date
2016-12-31
Last updated
2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

brachio-axillary, brachio-basilic, interfascial plane block, Pecs II block, supraclavicular brachial plexus block

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.

Interventions

Ultrasound-guided supraclavicular brachial plexus block

PROCEDUREPecs II block

Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior

PROCEDURESham block (Grade 1)

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

Local anaesthetic solution administered for supraclavicular block

DRUGRopivacaine 0.5% 10ml

Local anaesthetic solution administered for pecs II block

Sponsors

Changi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Need for intraoperative local anaesthetic supplementation by the surgeonIntraoperativeWhether there was a need for the surgeon to infiltrate a standardised local anaesthetic drug (0.5% ropivacaine) to the operative site during surgery

Secondary

MeasureTime frameDescription
Volume of intraoperative local anaesthetic supplementation administeredIntraoperativeTotal volume of local anaesthetic drug (0.5% ropivacaine) given by the surgeon
Need for additional sedation or systemic analgesiaIntraoperativeWhether there was a need for additional sedation or systemic analgesia (on top of what is specified in the protocol)
Time to first post-operative analgesiaUp to 24 hours post-operativelyDuration 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.
Highest pain score at Post-Anaesthesia Care Unit (PACU)Up to 1 hour post-operativelyHighest pain score on visual analogue scale at the post-anaesthesia care unit
Pain score at 24h24 hours post-operativelyPain score on visual analogue scale 24 hours after surgery
Patient satisfaction at 24hours24 hours post-operativelyPatient satisfaction with the anaesthesia technique on a 5-point Likert scale 24 hours after surgery
Pain score at 12h12 hours post-operativelyPain score on visual analogue scale 12 hours after surgery

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026