AzTrials
AzTrials

Arteriovenous FistulaNCT02331030

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

A study testing Supraclavicular, Pecs II block and Ropivacaine 0.5% 20ml in people with Arteriovenous Fistula and Arteriovenous Graft, run by Changi General Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 21 to 90 years
What is being tested?
Supraclavicular, Pecs II block and Ropivacaine 0.5% 20ml
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteSingapore
Study dates
Dec 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

About this study

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

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).

Read the 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.

Being tested
Supraclavicular, Pecs II block, Sham block (Grade 1), Ropivacaine 0.5% 20ml, Ropivacaine 0.5% 10ml
Keywords
brachio-axillary, brachio-basilic, interfascial plane block, Pecs II block, supraclavicular brachial plexus block
Medical subject headings
Arteriovenous Fistula, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SupraclavicularProcedure or surgery

    Ultrasound-guided supraclavicular brachial plexus block

  • Pecs II blockProcedure or surgery

    Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior

  • Sham block (Grade 1)Procedure or surgery

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

  • Ropivacaine 0.5% 20mlDrug

    Also called Naropin

    Local anaesthetic solution administered for supraclavicular block

  • Ropivacaine 0.5% 10mlDrug

    Also called Naropin

    Local anaesthetic solution administered for pecs II block

Study groups in NCT02331030
Study groupRoleWhat they receive
Combined (C)ExperimentalUltrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
Receives: Procedure: Supraclavicular; Procedure: Pecs II block; Drug: Ropivacaine 0.5% 20ml; Drug: Ropivacaine 0.5% 10ml
Supraclavicular (S)Active comparatorUltrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)
Receives: Procedure: Supraclavicular; Procedure: Sham block (Grade 1); Drug: Ropivacaine 0.5% 20ml

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Intraoperative

Secondary outcomes (7)

  1. Volume of intraoperative local anaesthetic supplementation administered

    Total volume of local anaesthetic drug (0.5% ropivacaine) given by the surgeon

    Measured: Intraoperative

  2. 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)

    Measured: Intraoperative

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

    Highest pain score on visual analogue scale at the post-anaesthesia care unit

    Measured: Up to 1 hour post-operatively

  4. 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.

    Measured: Up to 24 hours post-operatively

  5. Pain score at 12h

    Pain score on visual analogue scale 12 hours after surgery

    Measured: 12 hours post-operatively

  6. Pain score at 24h

    Pain score on visual analogue scale 24 hours after surgery

    Measured: 24 hours post-operatively

  7. Patient satisfaction at 24hours

    Patient satisfaction with the anaesthesia technique on a 5-point Likert scale 24 hours after surgery

    Measured: 24 hours post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02331030
Sponsor's protocol ID
2014/2047
Status last verified
Jul 2017
First submitted
31 Dec 2014
Last updated
19 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Confidentiality of individual subjects will be maintained strictly

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.

    PubMed 22939099

  • 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.

    PubMed 24686046

  • 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.

    PubMed 22116664

  • 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.

    PubMed 21367563

  • 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.

    PubMed 25302976

  • 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.

    PubMed 22383924

Questions about this trial

What is this clinical trial studying?

A study testing Supraclavicular, Pecs II block and Ropivacaine 0.5% 20ml in people with Arteriovenous Fistula and Arteriovenous Graft, run by Changi General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for intraoperative local anaesthetic supplementation by the surgeon (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02331030, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in