Supraclavicular Versus Axillary Block for Arteriovenous (AV) Fistula Creation
CUGSCAB
Comparison of Efficacy of Ultrasound-Guided Supraclavicular and Axillary Block for Arterio-Venous Fistula Creation: An Observer-Blinded, Non-inferiority Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
This study compares the analgesic efficacy of supraclavicular brachial plexus nerve block to axillary nerve block techniques in adults undergoing AV fistula creation. Both these techniques will be done under ultrasound guidance, using the same local anesthetic drug. 120 patients will be included in this study, 60 patients for each technique. This study will help us know better regional anesthesia techniques, the additional need for analgesia/anesthesia, and the recovery rate following either of the blocks for AV fistula surgery. An interim analysis will be done after recruiting 50% of cases (30 cases) in both arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedStudy Start
First participant enrolled
August 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedNovember 22, 2023
November 1, 2023
1.3 years
February 22, 2023
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Requirement of additional analgesics intraoperatively or block failure (conversion to general anaesthesia)
Paracetamol 15 mg/kg or Fentanyl 0.5 mics/kg or local infiltration or change to General Anesthesia
20 minutes to 2 hours 30 minutes
Secondary Outcomes (2)
Time of motor recovery of block
up to 24 hours
Rate of complications
up to 24 hours
Other Outcomes (1)
Brachial artery diameter
0 to 3 hours
Study Arms (2)
Supraclavicular block
ACTIVE COMPARATORIn the supraclavicular group, the ultrasound probe will be positioned in the supraclavicular fossa, pointing caudad and locating the subclavian artery. The first rib is identified deep to the artery, and the hyperechoic pleura will be identified by sliding lung sign. The brachial plexus is consistently found with a characteristic ''honeycomb'' appearance lateral and superficial to the subclavian artery and superior to the first rib. The needle will be introduced through the skin from lateral to medial, in-plane with the transducer, with constant visualization, and directed toward the deep border of the nerve group. Three separate injections will be made at various sites in the bundle, tending to start deep, in the ''corner pocket'' close to the artery, and moving more superficially. The local anesthetics will be Lidocaine 2% 10 ml + Levobupivacaine 0.5% 10 ml.
Axillary block
ACTIVE COMPARATORPatients in the axillary group are placed in the supine position with the arm to be blocked, abducted and externally rotated. After sterilization of the axilla, the Ultrasound probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and surrounding radial, ulnar, and median nerve, appearing as hypo-echoic round structures around the axillary artery. The musculocutaneous nerve will also be identified between the coracobrachialis and biceps muscle or in either of them. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe, and then 0.5% bupivacaine will be injected around branches of the brachial plexus. The local anesthetics will be Lidocaine 2% 10 ml + Levobupivacaine 0.5% 15 ml. In this block, 5-7 ml of local anesthetic will block each nerve.
Interventions
brachial plexus nerve block by supraclavicular route
brachial plexus nerve block by axillary route
Eligibility Criteria
You may qualify if:
- Age \>18 years old
- Patients undergoing AV fistula creation in the antecubital fossa
You may not qualify if:
- \- Patient Refusal
- Hemodynamically unstable patient
- Local infection over the insertion site
- Coagulopathy
- Known allergy to Local Anaesthetic medications
- Abnormal anatomy
- Use of antiplatelet within 7 days of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sultan Qaboos University Hospital
Muscat, 123, Oman
Related Links
- Shrestha, N. et al. (2020) "delayed neurological recovery after ultrasound-guided brachial plexus block: A case report," Local and Regional Anesthesia, Volume 13, pp. 33-35. Available at: https://doi.org/10.2147/lra.s250989
- Subbiah, V. et al. (2018) "Observational study of the efficacy of supraclavicular brachial plexus block for arteriovenous fistula creation," Indian Journal of Anaesthesia, 62(8), p. 616. Available at: https://doi.org/10.4103/ija.ija\_293\_18.
- Monte, A.I. et al. (2011) "Comparison between local and regional anesthesia in arteriovenous fistula creation," The Journal of Vascular Access, 12(4), pp. 331-335. Available at: https://doi.org/10.5301/jva.2011.8560.
- Hussien, R.M. and Ibrahim, D.A. (2018) "Ultrasound guided axillary brachial plexus block versus supraclavicular block in emergency crushed hand patients : A comparative study," The Open Anesthesia Journal, 12(1), pp. 34-41.
- Ferré, F. et al. (2019) "Hemidiaphragmatic paralysis after ultrasound-guided supraclavicular block: A prospective cohort study," Brazilian Journal of Anesthesiology (English Edition), 69(6), pp. 580-586.
- Gauss, A. et al. (2014) "Incidence of clinically symptomatic pneumothorax in ultrasound-guided infraclavicular and supraclavicular brachial plexus block," Anaesthesia, 69(4), pp. 327-336.
- Arab, S.A. et al. (2014) "Ultrasound-guided supraclavicular brachial plexus block," Anesthesia \& Analgesia, 118(5), pp. 1120-1125. Available at: https://doi.org/10.1213/ane.0000000000000155.
- Bhatia, A. et al. (2010) "Pneumothorax as a complication of the ultrasound-guided supraclavicular approach for brachial plexus block," Anesthesia \& Analgesia, 111(3), pp. 817-819. Available at: https://doi.org/10.1213/ane.0b013e3181e42908
- Gao, C. et al. (2020) "Comparison of regional and local anesthesia for arteriovenous fistula creation in end-stage renal disease: A systematic review and meta-analysis." Available at: https://doi.org/10.21203/rs.3.rs-25806/v1.
- Nofal, W.H. et al. (2017) "Ultrasound-guided axillary brachial plexus block versus local infiltration anesthesia for arteriovenous fistula creation at the forearm for hemodialysis in patients with chronic renal failure," Saudi Journal of Anaesthesia
- Stav, A. et al. (2016) "Comparison of the supraclavicular, infraclavicular and axillary approaches for ultrasound-guided brachial plexus block for surgical anesthesia," Rambam Maimonides Medical Journal, 7(2)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jyoti Burad, MD, EDIC
Sultan Qaboos University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The investigator and assessor will be blinded. The block performer anaesthetist and the patient will know the technique.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior specialist
Study Record Dates
First Submitted
February 22, 2023
First Posted
April 12, 2023
Study Start
August 7, 2023
Primary Completion
December 1, 2024
Study Completion
May 1, 2025
Last Updated
November 22, 2023
Record last verified: 2023-11