Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02312453
Other study ID # 1038.76
Secondary ID
Status Completed
Phase N/A
First received November 28, 2014
Last updated December 6, 2014
Start date November 2012
Est. completion date October 2013

Study information

Verified date December 2014
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority Malaysia: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Abstract

Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach. A new posterior parasagittal in-plane ultrasound-guided infraclavicular approach was introduced to improve needle visibility. However no further follow up study was done.

Methods: We performed a case series and a cadaveric dissection to assess its feasibility in a single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia from November 2012 to October 2013. After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre, 18 patients undergoing upper limb surgery were prospectively recruited. A cadaveric dissection was also performed. The endpoints of this study were the success rate, performance time, total anaesthesia related time, quality of anaesthesia and any incidence of complications.


Description:

Introduction Our study focus on the ultrasound guided infraclavicular brachial plexus block, which is a cord-level block of the brachial plexus for surgical procedures below mid-humerus. The brachial plexus at this level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach (lateral para-sagittal in-plane technique).1

A new ultrasound-guided posterior approach parasagittal in-plane infraclavicular block was introduced to improve needle visibility.2 However no further follow up study was done.

Therefore, we performed a case series of 18 patients with a cadaveric dissection, to assess the feasibility of this approach.

Methods After obtaining ethics committee approval from the Medical Ethics Committee, University Malaya Medical Center, Kuala Lumpur, Malaysia (Chairperson Professor Dr. Looi Lai Meng; IRB reference no. 949.14 dated 17 October 2012, amendment no.1038.76 dated 19 December 2013) and written informed consent, 18 patients undergoing surgery of the elbow, forearm, wrist, or hand were prospectively recruited based on the criteria below.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- patient's age between 18 and 80 years old,

- American Society of Anesthesiologists (ASA) physical status I - III,

- body mass index (BMI) between 20 and 35 kg/m2 and

- planned for surgery of the forearm, wrist, or hand.

Exclusion Criteria:

- patient's inability to give consent to the study,

- pre-existing neuropathy,

- infection at the site of puncture,

- coagulopathy, and

- allergy to amides local anaesthetics.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Procedure:
Posterior approach
We adopted the technique as described by Hebbard et al.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

References & Publications (1)

References 1. Chin KJ, Perlas A, Chan VW, et al. Needle visualization in ultrasound guided regional anaesthesia: challenges and solutions. Reg Anesth Pain Med 2008; 33:532-544 2. Hebbard P and Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia 2007; 62: 539 3. Levesque S, Dion N, Desgagne MC. Endpoint for successful, ultrasound-guided infraclavicular brachial plexus block. Can J Anaesth 2008; 55:308. 4. Tran DQH, Charghi R, Finlayson RJ. The 'Double Bubble' Sign for Successful Infraclavicular Brachial Plexus Blockade. Anesth Analg 2006; 103:1048-1049 5. Tran DQH, Bertini P, Zaouter C, et al. A Prospective, Randomized Comparison Between Single- and Double-Injection Ultrasound-Guided Infraclavicular Brachial Plexus Block. Reg Anesth Pain Med 2010; 35:16-21 6. Tran DQH, Munoz L, Zaouter C, et al. A prospective, randomized comparison between single- and double-injection ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med 2009; 34:420-424. 7. Tran DQH, Russo G, Munoz L, et al. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular and axillary brachial plexus blocks. Reg Anesth Pain Med 2009; 34:366-371

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate (ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon) Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon
The adequacy of block was determined during assessment of motor and sensory blockade at predetermined intervals, every 5 minutes until 30 minutes; Please refer to the study detailed description.
participants will be followed up throughout operation duration No
Secondary Performance parameters Imaging time (defined as the time interval between contact of the ultrasound probe with the patient and the acquisition of a satisfactory sonoanatomy - a complete round short-axis view of the axillary artery) Needling time (defined as the time interval between the start of the needle insertion and the end of local anaesthetic injection through the needle) Performance time (defined as the sum of imaging and needling times). participants will be followed up throughout the procedure No
Secondary Safety aspects and potential complications as measured by incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity The incidence of paraesthesia and vascular puncture was recorded if any. Horner's syndrome, dyspnoea and symptoms suggestive of local anaesthetic toxicity were routinely checked. participants will be followed up throughout procedure, during operation and 1 week after the operation (via phone call) Yes
Secondary adequacy of block for tourniquet application The incidence of tourniquet pain participants will be followed up throughout operation No
See also
  Status Clinical Trial Phase
Withdrawn NCT04053491 - Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block. N/A
Completed NCT03211949 - Ultrasound Guided Topographic Mapping of Medial Antebrachial Cutaneous Nerve N/A
Suspended NCT03291691 - Protective Nerve Stimulation in Regional Anesthesia
Completed NCT03270033 - Intravenous Dexmedetomidine, Dexamethasone and Interscalene Block Duration After Arthroscopic Shoulder Surgery Phase 4
Recruiting NCT06015204 - Assessment of the C8 Dermatomal Block With Photoplethysmographic Amplitude After Interscalene Brachial Plexus Block N/A
Not yet recruiting NCT03279679 - Comparison Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery N/A
Completed NCT02305875 - The Musculocutaneous Nerve in a High Resolution MRI N/A
Completed NCT03688724 - Perioperative Diaphragm Point of Care Ultrasound
Completed NCT05005260 - Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty Phase 4
Completed NCT02462408 - Conventional Versus Posterior Approach in Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block N/A
Completed NCT00321425 - Ultrasound Guidance Vs. Electrical Nerve Stimulation for Infraclavicular Brachial Plexus Block N/A
Recruiting NCT03577860 - Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block N/A
Completed NCT04356521 - Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block N/A
Completed NCT04463329 - Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block N/A
Not yet recruiting NCT04784104 - Comparison of Infraclavicular And Supraclavicular Block Phase 4
Terminated NCT03785392 - Out of Plane Approach for Interscalene N/A
Completed NCT02787018 - Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block Phase 3
Completed NCT03514342 - The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity
Completed NCT05315271 - Supraclavicular Brachial Plexus Block During Upper Limb Surgeries Early Phase 1
Completed NCT04694105 - Peri-neural Dexmedetomidine Versus Dexamethasone for Supraaclavicular Block Adjuvant to Bupivacaine Supraclavicular Brachial Plexus Block N/A