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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331030
• Other study ID #: 2014/2047
• Status: Completed
• Phase: N/A
• First received: December 31, 2014
• Last updated: July 17, 2017
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Supraclavicular
Ultrasound-guided supraclavicular brachial plexus block
• Pecs II block
Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior
• Sham block (Grade 1)
Sham block -- with skin preparation, ultrasound scanning of pecs II block area, but no actual needle injection

Drug:
• Ropivacaine 0.5% 20ml
Local anaesthetic solution administered for supraclavicular block
• Ropivacaine 0.5% 10ml
Local anaesthetic solution administered for pecs II block

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Volume of intraoperative local anaesthetic supplementation administered	Total volume of local anaesthetic drug (0.5% ropivacaine) given by the surgeon	Intraoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain score at 12h	Pain score on visual analogue scale 12 hours after surgery	12 hours post-operatively
Secondary	Pain score at 24h	Pain score on visual analogue scale 24 hours after surgery	24 hours post-operatively
Secondary	Patient satisfaction at 24hours	Patient satisfaction with the anaesthesia technique on a 5-point Likert scale 24 hours after surgery	24 hours post-operatively