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

Primary Purpose

Arteriovenous Fistula, Arteriovenous Graft, Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Supraclavicular
Pecs II block
Sham block (Grade 1)
Ropivacaine 0.5% 20ml
Ropivacaine 0.5% 10ml
Sponsored by
Changi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistula focused on measuring brachio-axillary, brachio-basilic, interfascial plane block, Pecs II block, supraclavicular brachial plexus block

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Changi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined (C)

Supraclavicular (S)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Volume of intraoperative local anaesthetic supplementation administered
Total volume of local anaesthetic drug (0.5% ropivacaine) given by the surgeon
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)
Highest pain score at Post-Anaesthesia Care Unit (PACU)
Highest pain score on visual analogue scale at the post-anaesthesia care unit
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.
Pain score at 12h
Pain score on visual analogue scale 12 hours after surgery
Pain score at 24h
Pain score on visual analogue scale 24 hours after surgery
Patient satisfaction at 24hours
Patient satisfaction with the anaesthesia technique on a 5-point Likert scale 24 hours after surgery

Full Information

First Posted
December 31, 2014
Last Updated
July 17, 2017
Sponsor
Changi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02331030
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changi General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined (C)
Arm Type
Experimental
Arm Description
Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
Arm Title
Supraclavicular (S)
Arm Type
Active Comparator
Arm Description
Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)
Intervention Type
Procedure
Intervention Name(s)
Supraclavicular
Intervention Description
Ultrasound-guided supraclavicular brachial plexus block
Intervention Type
Procedure
Intervention Name(s)
Pecs II block
Intervention Description
Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior
Intervention Type
Procedure
Intervention Name(s)
Sham block (Grade 1)
Intervention Description
Sham block -- with skin preparation, ultrasound scanning of pecs II block area, but no actual needle injection
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% 20ml
Other Intervention Name(s)
Naropin
Intervention Description
Local anaesthetic solution administered for supraclavicular block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% 10ml
Other Intervention Name(s)
Naropin
Intervention Description
Local anaesthetic solution administered for pecs II block
Primary Outcome Measure Information:
Title
Need for intraoperative local anaesthetic supplementation by the surgeon
Description
Whether there was a need for the surgeon to infiltrate a standardised local anaesthetic drug (0.5% ropivacaine) to the operative site during surgery
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Volume of intraoperative local anaesthetic supplementation administered
Description
Total volume of local anaesthetic drug (0.5% ropivacaine) given by the surgeon
Time Frame
Intraoperative
Title
Need for additional sedation or systemic analgesia
Description
Whether there was a need for additional sedation or systemic analgesia (on top of what is specified in the protocol)
Time Frame
Intraoperative
Title
Highest pain score at Post-Anaesthesia Care Unit (PACU)
Description
Highest pain score on visual analogue scale at the post-anaesthesia care unit
Time Frame
Up to 1 hour post-operatively
Title
Time to first post-operative analgesia
Description
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.
Time Frame
Up to 24 hours post-operatively
Title
Pain score at 12h
Description
Pain score on visual analogue scale 12 hours after surgery
Time Frame
12 hours post-operatively
Title
Pain score at 24h
Description
Pain score on visual analogue scale 24 hours after surgery
Time Frame
24 hours post-operatively
Title
Patient satisfaction at 24hours
Description
Patient satisfaction with the anaesthesia technique on a 5-point Likert scale 24 hours after surgery
Time Frame
24 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelvin Quek, MMED (Anaes)
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Confidentiality of individual subjects will be maintained strictly
Citations:
PubMed Identifier
22939099
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.
Results Reference
background
PubMed Identifier
24686046
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.
Results Reference
background
PubMed Identifier
22116664
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.
Results Reference
background
PubMed Identifier
21367563
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.
Results Reference
background
PubMed Identifier
25302976
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.
Results Reference
background
PubMed Identifier
22383924
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.
Results Reference
background

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

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