Clinical trial NCT02331030: A Randomised Trial Comparing Supraclavicular Block vs Supraclavicular and Pecs II Block in Arteriovenous Grafting
Official title: A Randomised Controlled Trial Comparing Ultrasound-guided Supraclavicular Brachial Plexus Block With Combined Supraclavicular and Pecs II Block in Patients Undergoing Arteriovenous Grafting Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Need for intraoperative local anaesthetic supplementation by the surgeon
timeFrame: Intraoperative
Secondary outcomes:
measure: Volume of intraoperative local anaesthetic supplementation administered
timeFrame: Intraoperative
measure: Need for additional sedation or systemic analgesia
timeFrame: Intraoperative
measure: Highest pain score at Post-Anaesthesia Care Unit (PACU)
timeFrame: Up to 1 hour post-operatively
measure: Time to first post-operative analgesia
timeFrame: Up to 24 hours post-operatively
measure: Pain score at 12h
timeFrame: 12 hours post-operatively
measure: Pain score at 24h
timeFrame: 24 hours post-operatively
measure: Patient satisfaction at 24hours
timeFrame: 24 hours post-operatively
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Kelvin Quek, MMED (Anaes)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
citation: Arab SA, Alharbi MK, Nada EM, Alrefai DA, Mowafi HA. Ultrasound-guided supraclavicular brachial plexus block: single versus triple injection technique for upper limb arteriovenous access surgery. Anesth Analg. 2014 May;118(5):1120-5. doi: 10.1213/ANE.0000000000000155.
citation: Reynolds TS, Kim KM, Dukkipati R, Nguyen TH, Julka I, Kakazu C, Tokhner V, Chauvapun JP. Pre-operative regional block anesthesia enhances operative strategy for arteriovenous fistula creation. J Vasc Access. 2011 Oct-Dec;12(4):336-40. doi: 10.5301/JVA.2011.8827.
citation: Sahin L, Gul R, Mizrak A, Deniz H, Sahin M, Koruk S, Cesur M, Goksu S. Ultrasound-guided infraclavicular brachial plexus block enhances postoperative blood flow in arteriovenous fistulas. J Vasc Surg. 2011 Sep;54(3):749-53. doi: 10.1016/j.jvs.2010.12.045. Epub 2011 Mar 2.
citation: Purcell N, Wu D. Novel use of the PECS II block for upper limb fistula surgery. Anaesthesia. 2014 Nov;69(11):1294. doi: 10.1111/anae.12876. No abstract available.
citation: Sariguney D, Mahli A, Coskun D. The extent of blockade following axillary and infraclavicular approaches of brachial plexus block in uremic patients. J Clin Med Res. 2012 Feb;4(1):26-32. doi: 10.4021/jocmr723w. Epub 2012 Jan 17.