Conventional Versus Posterior Approach in Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block

Brachial Plexus Block Clinical Trial

Official title:

A Prospective, Randomized Comparison Between Lateral and Posterior Approach In Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462408
• Other study ID #: 949.14
• Status: Completed
• Phase: N/A
• First received: April 1, 2015
• Last updated: June 1, 2015
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2015
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided infraclavicular brachial plexus block. However this technique is less popular because brachial plexus at the infraclavicular level runs deeper compared to its course proximally, often give rise to impaired needle visualisation due to its steep angle of needle trajectory to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to improve needle visibility. This approach proved feasible from our case series hence the investigators would like to compare it with the conventional method in this study

Description:

This study compared the conventional lateral and posterior approach parasagittal in-plane ultrasound guided infraclavicular brachial plexus block for upper limb surgery. A cadaveric study was also performed to complement the findings.

After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre (IRB reference no. 949.14 dated 17 October 2012), 46 patients undergoing upper limb surgery were prospectively recruited and randomized. A cadaveric dissection was also performed.

DESIGN: Prospective randomized study

SETTING: Single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia; November 2012 to October 2013

INTERVENTION: Ultrasound guided, lateral or posterior parasagittal in-plane infraclavicular brachial plexus blocks were performed on patients, depending on randomization. All blocks were performed using 21G x 4 inch Stimuplex A (B Braun Medical) without nerve stimulation plus SonoSite M-Turbo with HFL38x/ 13-6 MHz linear transducer probe. A 25-ml local anaesthetic admixture [Lignocaine 2% (100mg) plus Ropivacaine 0.75% (150mg)] were injected to all patients. A total volume of normal saline 0.9% 25ml mixed with methylene blue (0.2ml) was used for cadaveric study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• 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:

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

• Body Mass Index (BMI) between 20 and 35 kg/m2

• Surgery of the forearm, wrist, or hand

Exclusion Criteria:

• Inability to give consent to the study

• Pre-existing neuropathy

• Infection at the site of puncture, skin ulcer

• Coagulopathy

• Contralateral phrenic nerve paralysis, contralateral recurrent laryngeal nerve paralysis or pneumothorax

• Allergy to amides local anaesthetics

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brachial Plexus Block
• Infraclavicular
• Ultrasound Guided

Intervention

Procedure:
• Posterior approach
The needle insertion point was over the trapezius muscle sufficiently posterior to allow the needle to pass between the clavicle and the scapula in the direction of the axillary artery. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.
• Conventional approach
The needle insertion point would be at the cephalad (lateral) aspect of the ultrasound probe, beneath the clavicle and medial to the coracoid process. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

References & Publications (4)

Chin KJ, Perlas A, Chan VW, Brull R. Needle visualization in ultrasound-guided regional anesthesia: challenges and solutions. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):532-44. Review. — View Citation

Hebbard P, Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia. 2007 May;62(5):539. — View Citation

Tran DQ, Bertini P, Zaouter C, Muñoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c. — View Citation

Tran DQ, Charghi R, Finlayson RJ. The "double bubble" sign for successful infraclavicular brachial plexus blockade. Anesth Analg. 2006 Oct;103(4):1048-9. — View Citation

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 the operation duration; as stated each operation has variable duration of operation time, average operation time 2 to 4 hours	No
Secondary	Performance parameters	This is a composite outcome measure. The anaesthesia assistant would record the time required to perform the procedure as follow below description: (i)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), (ii) Needling time (defined as the time interval between the start of the needle insertion and the end of local anaesthetic injection through the needle), (iii) Performance time (defined as the sum of imaging and needling times). This timing definition had been published in other journals (please refer our references - 3)	participants will be followed up throughout the procedure (performing the blocks), average time for block perfomances 30 minutes	No
Secondary	Safety aspects and potential complications; we measured by any incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity	This is a composite outcome measure. We measured safety aspects and potential complications by recording any incidence of paraesthesia and vascular puncture during block performances, any Horner's syndrome, dyspnoea and symptoms suggestive of local anaesthetic toxicity were routinely checked after the procedure and during surgery. To further enhance patient's safety, we would still follow up patient by phone call 1 week after the surgery	Participants would be followed up throughout procedure (average duration 30 minutes), during operation (average duration 2 to 4 hours) and 1 week after the operation (via phone call)	Yes
Secondary	adequacy of block for tourniquet application	The incidence of tourniquet pain; this would describe whether the block technique covers for tourniquet pain	participants would be followed up throughout the operation duration whether they complained of pain at torniquet site during the operation duration; average duration of operation 2 - 4 hours	No