Clinical trial NCT02462408: Conventional Versus Posterior Approach in Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block
Official title: A Prospective, Randomized Comparison Between Lateral and Posterior Approach In Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brachial Plexus Block
Infraclavicular
Ultrasound Guided
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate (ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon)
timeFrame: 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
Secondary outcomes:
measure: Performance parameters
timeFrame: participants will be followed up throughout the procedure (performing the blocks), average time for block perfomances 30 minutes
measure: Safety aspects and potential complications; we measured by any incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity
timeFrame: 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)
measure: adequacy of block for tourniquet application
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaya
name: Beh Zhi Yuen, MD, M.Anaes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.rapm.2008.06.002.
citation: Hebbard P, Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia. 2007 May;62(5):539. doi: 10.1111/j.1365-2044.2007.05066.x. No abstract available.
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. doi: 10.1213/01.ane.0000239077.49794.a5. No abstract available.
citation: Tran DQ, Bertini P, Zaouter C, Munoz 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.