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NCT Number: NCT02331030

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

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).

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Key information

Conditions

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

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Supraclavicular

Procedure

Ultrasound-guided supraclavicular brachial plexus block

PECS II block

Procedure

Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior

Sham block (Grade 1)

Procedure

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

Ropivacaine 0.5% 20ml

Drug

Local anaesthetic solution administered for supraclavicular block

Other names: Naropin

Ropivacaine 0.5% 10ml

Drug

Local anaesthetic solution administered for pecs II block

Other names: Naropin

Primary outcomes

  1. Need for intraoperative local anaesthetic supplementation by the surgeon

    Time frame: Intraoperative

    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 outcomes

  1. Volume of intraoperative local anaesthetic supplementation administered

    Time frame: Intraoperative

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

  2. Need for additional sedation or systemic analgesia

    Time frame: Intraoperative

    Whether there was a need for additional sedation or systemic analgesia (on top of what is specified in the protocol)

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

    Time frame: Up to 1 hour post-operatively

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

  4. Time to first post-operative analgesia

    Time frame: Up to 24 hours post-operatively

    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.

  5. Pain score at 12h

    Time frame: 12 hours post-operatively

    Pain score on visual analogue scale 12 hours after surgery

  6. Pain score at 24h

    Time frame: 24 hours post-operatively

    Pain score on visual analogue scale 24 hours after surgery

  7. Patient satisfaction at 24hours

    Time frame: 24 hours post-operatively

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

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2015
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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