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

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).

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic; Arteriovenous Fistula; Arteriovenous Graft; Renal Failure, End-stage
• Intervention / Treatment: Procedure: Supraclavicular; Procedure: Pecs II block; Drug: Ropivacaine 0.5% 20ml; Drug: Ropivacaine 0.5% 10ml; Procedure: 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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Changi General Hospital
• Investigators: Principal Investigator: Kelvin Quek, MMED (Anaes), Changi General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 31, 2014
• First Submitted That Met QC Criteria: January 1, 2015
• First Posted (Estimate): January 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: interfascial plane block; supraclavicular brachial plexus block; brachio-axillary; brachio-basilic; Pecs II block
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Failure, Chronic; Fistula; Renal Insufficiency; Arteriovenous Fistula; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2014/2047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidentiality of individual subjects will be maintained strictly