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

NCT02331030 | Completed

• 1 other identifier: 2014/2047
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Volume of intraoperative local anaesthetic supplementation administered

  Intraoperative

• Need for additional sedation or systemic analgesia

  Intraoperative

• Highest pain score at Post-Anaesthesia Care Unit (PACU)

  Up to 1 hour post-operatively

• Time to first post-operative analgesia

  Up to 24 hours post-operatively

• Pain score at 12h

  12 hours post-operatively

Study Arms (2)

Combined (C)

EXPERIMENTAL

Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.

Procedure: Supraclavicular; Procedure: Pecs II block; Drug: Ropivacaine 0.5% 20ml; Drug: Ropivacaine 0.5% 10ml

Supraclavicular (S)

ACTIVE COMPARATOR

Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)

Procedure: Supraclavicular; Procedure: Sham block (Grade 1); Drug: Ropivacaine 0.5% 20ml

Interventions

Supraclavicular PROCEDURE

Ultrasound-guided supraclavicular brachial plexus block

Combined (C); Supraclavicular (S)

Pecs II block PROCEDURE

Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior

Combined (C)

Sham block (Grade 1) PROCEDURE

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

Supraclavicular (S)

Ropivacaine 0.5% 20ml DRUG

Local anaesthetic solution administered for supraclavicular block

Also known as: Naropin

Combined (C); Supraclavicular (S)

Ropivacaine 0.5% 10ml DRUG

Local anaesthetic solution administered for pecs II block

Also known as: Naropin

Combined (C)

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (6)

• 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.

  PMID: 22939099 BACKGROUND

• 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.

  PMID: 24686046 BACKGROUND

• 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.

  PMID: 22116664 BACKGROUND

• 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.

  PMID: 21367563 BACKGROUND

• 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.

  PMID: 25302976 BACKGROUND

• 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.

  PMID: 22383924 BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula; Kidney Failure, Chronic

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kelvin Quek, MMED (Anaes)

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 5, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)