Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb

Hand Injury Clinical Trial

Official title:

Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb: a Multi-centric Non-inferiority Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913625
• Other study ID #: MP-31-2017-1298
• Status: Completed
• Phase: N/A
• First received: September 12, 2016
• Last updated: July 3, 2017
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Locoregional anesthesia provides several advantages over general anesthesia in terms of postoperative pain, decreased postoperative opioid needs and reduced recovery time for patients undergoing orthopaedic surgery.

For upper limb surgery, the coracoid infraclavicular brachial plexus block is generally preferred because of its simplicity and effectiveness but, needle visibility remains a challenge because of the angle between the ultrasound beam and the needle.

The retroclavicular approach for brachial plexus anesthesia requires an angle between the needle and the ultrasound beam that is less steep than the angle required to perform an infraclavicular coracoid block. This approach has already been proven effective and safe in the past.

The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study will delineate the differences between the two techniques.

Description:

Investigators aim is to compare both techniques in terms of scanning time, needling time, total anesthesia time, needle visibility, block needle passes, block success and early and late complications. Investigators made the hypothesis that, while providing similar efficacy and better needle visualisation than coracoid infraclavicular block, performance time of retroclavicular block will not exceed the performance time of its comparator.

This study is designed as a prospective randomized non-inferiority trial. Two groups of non-consecutive patients will be randomly assigned to either retroclavicular or coracoid infraclavicular block. This study will be carried out in three different centres simultaneously.

The multicentre trial will be conducted in two university hospitals (Centre hospitalier universitaire de Sherbrooke [CHUS] Hôtel-Dieu/Fleurimont and Centre Hospitalier de l'Université Laval [CHUL] in Quebec city) and a community hospital (Cowansville). The third participating establishment, Brome-Missisquoi-Perkins hospital, is located in Cowansville, a peripheral city of 15,000 people.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective or urgent surgery of the hand, wrist, forearm or elbow.

• Age >18 years old.

• ASA (American Society of Anesthesiologists) class 1, 2 and 3.

• Able to provide valid written consent.

• Minimum body weight of 50 kg, despite BMI

Exclusion Criteria:

• Patient refusal.

• Previous surgery or gross anatomical deformity of the clavicle.

• Systemic or local infection at needle entry point.

• Coagulopathy.

• Severe pulmonary condition.

• Local anaesthetic allergy.

• Pre-existing neurologic symptoms in the ipsilateral limb.

• Pregnancy.

• Surgical request of an indwelling catheter for post-operative analgesia

Related Conditions & MeSH terms

• Hand Injuries
• Hand Injury

Intervention

Other:
• Ultrasound guided retroclavicular block
Ultrasound guided retroclavicular block for forearm or hand surgery
• Ultrasound guided infraclavicular block
Ultrasound guided infraclavicular block for forearm or hand surgery

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université Laval [CHUL]	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & Publications (15)

Beh ZY, Hasan MS, Lai HY, Kassim NM, Md Zin SR, Chin KF. Posterior parasagittal in-plane ultrasound-guided infraclavicular brachial plexus block-a case series. BMC Anesthesiol. 2015 Jul 21;15:105. doi: 10.1186/s12871-015-0090-0. — View Citation

Bruce BG, Green A, Blaine TA, Wesner LV. Brachial plexus blocks for upper extremity orthopaedic surgery. J Am Acad Orthop Surg. 2012 Jan;20(1):38-47. doi: 10.5435/JAAOS-20-01-038. Review. — View Citation

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. — View Citation

Charbonneau J, Fréchette Y, Sansoucy Y, Echave P. The Ultrasound-Guided Retroclavicular Block: A Prospective Feasibility Study. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):605-9. doi: 10.1097/AAP.0000000000000284. — View Citation

Chin KJ, Alakkad H, Adhikary SD, Singh M. Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. Cochrane Database Syst Rev. 2013 Aug 28;(8):CD005487. doi: 10.1002/14651858.CD005487.pub3. Review. — View Citation

de Gusmão LC, Lima JS, Ramalho Jda R, Leite AL, da Silva AM. Evaluation of brachial plexus fascicles involvement on infraclavicular block: unfixed cadaver study. Braz J Anesthesiol. 2015 May-Jun;65(3):213-6. doi: 10.1016/j.bjane.2014.06.010. Epub 2015 Feb 17. — View Citation

Hadzic A, Arliss J, Kerimoglu B, Karaca PE, Yufa M, Claudio RE, Vloka JD, Rosenquist R, Santos AC, Thys DM. A comparison of infraclavicular nerve block versus general anesthesia for hand and wrist day-case surgeries. Anesthesiology. 2004 Jul;101(1):127-32. — View Citation

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

López-Morales S, Moreno-Martín A, Leal del Ojo JD, Rodriguez-Huertas F. [Ultrasound-guided axillary block versus ultrasound-guided infraclavicular block for upper extremity surgery]. Rev Esp Anestesiol Reanim. 2013 Jun-Jul;60(6):313-9. doi: 10.1016/j.redar.2013.02.012. Epub 2013 May 15. Spanish. — View Citation

Minville V, Asehnoune K, Chassery C, N'Guyen L, Gris C, Fourcade O, Samii K, Benhamou D. Resident versus staff anesthesiologist performance: coracoid approach to infraclavicular brachial plexus blocks using a double-stimulation technique. Reg Anesth Pain Med. 2005 May-Jun;30(3):233-7. — View Citation

Tran DQ, Clemente A, Tran DQ, Finlayson RJ. A comparison between ultrasound-guided infraclavicular block using the "double bubble" sign and neurostimulation-guided axillary block. Anesth Analg. 2008 Sep;107(3):1075-8. doi: 10.1213/ane.0b013e31817ef259. — View Citation

Trehan V, Srivastava U, Kumar A, Saxena S, Singh CS, Darolia A. Comparison of two approaches of infraclavicular brachial plexus block for orthopaedic surgery below mid-humerus. Indian J Anaesth. 2010 May;54(3):210-4. doi: 10.4103/0019-5049.65362. — View Citation

Tsui, B.C.-H., Atlas of ultrasound and nerve stimulation-guided regional anesthesia. 2007: New York : Springer.

Vermeylen K, Engelen S, Sermeus L, Soetens F, Van de Velde M. Supraclavicular brachial plexus blocks: review and current practice. Acta Anaesthesiol Belg. 2012;63(1):15-21. Review. — View Citation

Yazer MS, Finlayson RJ, Tran DQ. A randomized comparison between infraclavicular block and targeted intracluster injection supraclavicular block. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):11-5. doi: 10.1097/AAP.0000000000000193. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of block performance	The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes.; Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.; Subgroup analysis will be conducted to evaluate if higher body mass index influence (BMI) the outcomes, as the performance time, the needle visibility, the number of needle passes and the needle angle. Patient will be divided in two groups (higher and lower than the average BMI of all recruited patients) and analyzed according to their subgroup. If data is missing or if patient drop-out occurs, data will be analyzed with the intention-to-treat principle.	Measured directly during the procedure with a chronometer. Time of performance is composed of imaging time and needling time
Secondary	Imaging time	Corresponds to the time interval between contact of the US probe with the patient skin and the acquisition of a satisfactory image. It is expressed in minutes.; The secondary outcomes will all be analyzed with superiority analysis. For continuous data or ordinal data with >8 categories, data will be compiled as average and standard deviation. If data is parametric, student T test will be used and if not, Mann-Whitney test will be used. For dichotomic data (block success, use of neurostimulation), Chi square or Fisher exact test will be used depending if all n>5 or if not, respectively. Finally, for ordinal data Chi square will be used if data is parametric and Mann-Whitney will be used otherwise	Measured directly during the procedure with a chronometer.
Secondary	Needling time	Corresponds to the time elapsed between the penetration of the skin with the needle until the complete removal of the needle from the tissues.	Measured directly during the procedure with a chronometer.
Secondary	Time to sensory loss evaluated at 10, 20 and 30 minutes after procedure	Sensory loss will be assessed in the territory of the radial (lateral aspect of the dorsum of the hand), median (volar aspect of the index), ulnar (volar aspect of the fifth finger), musculocutaneous (lateral aspect of the forearm), and medial cutaneous nerve of the forearm (medial aspect of the forearm) distributions using a 3-point score, where 0 = normal sensation, 1 = diminished sensation to pinpricks (hypoesthesia), and 2 = loss of sensation to pinpricks (analgesia). The sum of five scores on a maximum of 10 will be the sensory loss final score. An independent, blinded, research assistant will complete the sensory assessment at 10, 20 and 30 minutes after procedure	Blind assistant evaluates the loss of sensibility in 5 precise nerve territories, 10, 20 and 30 minutes after the block.
Secondary	Time to motor blockade evaluated at 10, 20 and 30 minutes after procedure	Motor function will be tested (0 = normal strength, 1 = weakness, 2 = paralysis) for the radial (wrist extension), median (thumb-fifth finger opposition), ulnar (fifth finger abduction), and musculocutaneous (elbow flexion) nerves. The sum of the four scores on a maximum of 8 will be the motor block final score. An independent, blinded, research assistant will complete the motor assessment at 10, 20 and 30 minutes after procedure	Blind assistant evaluates the loss of motor function in four muscular groups at 10, 20 and 30 minutes after the block.
Secondary	Success of plexus block	Success is defined as the completion of surgery without the need for additional local anesthetics infiltration, intravenous narcotics, or general anesthesia. However, light sedation is allowed if deemed necessary by the anesthesiologist. Light sedation includes midazolam 1 to 4 mg intravenously, fentanyl up to 1 mcg/kg. A minimum sensory score of 9/10 will be necessary to proceed to surgery without additional local anesthetics infiltration. Patients with an overall sensory score less than 9/10 at 30 minutes will be offered general anesthesia or supplemental blocks.	Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed
Secondary	Total anesthesia time	Measured in minutes and defined as the sum of performance time and time to achieve a minimum sensory score of 9/10. It is the time for readiness for surgery.	Intraoperative
Secondary	Number of needle passes	Defined as a unit of 1,2,3, etc. The number of times the block needle will have to be realigned at the skin in order to achieve its final positioning goal under the axillary artery.	Number of needle passes required during procedure.
Secondary	Needle visualization	Procedures will be videotaped and reviewed simultaneously after study completion by 2 independent anesthesiologists skilled in US-guided regional anesthesia using a 5-point Likert scale to rate needle visibility (1=very poor,2=poor,3=fair,4=good,5=very good). Needle visibility will be evaluated twice. First, for the retroclavicular approach, assessment will be done when needle tip is seen 1cm after crossing the clavicle acoustic shadowing. For the coracoid infraclavicular approach, the first assessment will be at a needle tip depth of 1 cm. Second needle visibility assessment will be immediately before local anesthetic injection when block needle is positioned under axillary artery (when the visibility is theoretically optimized)	Assessed one week after study completion
Secondary	Needle angle	Using the same videotape that investigators used for the evaluation of the needle visibility, the angle between the needle and the upper side of the ultrasound image will be noted. It will be a continuous outcome ranging from 0 to 90 degrees.	Assessed one week after study completion
Secondary	Neurostimulation use	Neurostimulation is accepted if needed. However, its use other than for safety sentinel (defined by <0,3 mA) will be recorded for subsequent analysis. It will be a dichotomic outcome.	Assessed during the block
Secondary	Pain during the procedure	Immediately after block completion, patients will be asked to rate their discomfort associated with the procedure using a 10-cm visual analogue scale (0 = no pain, 10 = worst pain imaginable) by an independent and blinded outcome assessor.	Patients will be asked to report the level of discomfort they felt during the procedure
Secondary	Early and late complications:	The incidence of needle-induced paresthesia, vascular puncture, Horner syndrome, dyspnea, and symptoms of local anesthetics toxicity will be noted. All patients will be contacted 48 hours after surgery to ask for any delayed complications, such as dyspnea, paresthesia, weaknesses, pain at the puncture site, hematoma.	Assessed during each block and again at 48 hours after the block