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

NCT02913625 | Completed

• 1 other identifier: MP-31-2017-1298
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hand Injury

Keywords

Brachial plexus; Regional anesthesia; Infraclavicular; Retroclavicular; Parasagittal; Upper limb surgery; Ultrasound guided block; Coracoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Imaging time

  Measured directly during the procedure with a chronometer.

• Needling time

  Measured directly during the procedure with a chronometer.

• Time to sensory loss evaluated 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.

• Time to motor blockade evaluated 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.

• Success of plexus block

  Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed

Study Arms (2)

Ultrasound guided retroclavicular block

EXPERIMENTAL

Patients assigned to this group will receive an ultrasound guided retroclavicular brachial plexus block

Other: Ultrasound guided retroclavicular block

Ultrasound guided infraclavicular block

ACTIVE COMPARATOR

Patients assigned to this group will receive an ultrasound guided infraclavicular brachial plexus block

Other: Ultrasound guided infraclavicular block

Interventions

Ultrasound guided retroclavicular block OTHER

Ultrasound guided retroclavicular block for forearm or hand surgery

Ultrasound guided retroclavicular block

Ultrasound guided infraclavicular block OTHER

Ultrasound guided infraclavicular block for forearm or hand surgery

Ultrasound guided infraclavicular block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (2)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier de l'Université Laval [CHUL]

Québec, G1V 4G2, Canada

Location

Related Publications (17)

• 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. doi: 10.1097/00000542-200407000-00020.

  PMID: 15220781 BACKGROUND

• 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.

  PMID: 22207517 BACKGROUND

• 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;2013(8):CD005487. doi: 10.1002/14651858.CD005487.pub3.

  PMID: 23986434 BACKGROUND

• Lopez-Morales S, Moreno-Martin 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.

  PMID: 23684374 BACKGROUND

• 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.

  PMID: 22783706 BACKGROUND

• 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.

  PMID: 20885866 BACKGROUND

• 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. doi: 10.1016/j.rapm.2005.01.009.

  PMID: 15898025 BACKGROUND

• de Gusmao 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.

  PMID: 25925034 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17448088 BACKGROUND

• Charbonneau J, Frechette 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.

  PMID: 26222346 BACKGROUND

• 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.

  PMID: 26194896 BACKGROUND

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson 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.

  PMID: 23303884 BACKGROUND

• 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.

  PMID: 18713932 BACKGROUND

• 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.

  PMID: 25478758 BACKGROUND

• Blanco AFG, Laferriere-Langlois P, Jessop D, D'Aragon F, Sansoucy Y, Albert N, Tetreault P, Echave P. Retroclavicular vs Infraclavicular block for brachial plexus anesthesia: a multi-centric randomized trial. BMC Anesthesiol. 2019 Oct 27;19(1):193. doi: 10.1186/s12871-019-0868-6.

  PMID: 31656165 DERIVED

• Langlois PL, Gil-Blanco AF, Jessop D, Sansoucy Y, D'Aragon F, Albert N, Echave P. Retroclavicular approach vs infraclavicular approach for plexic bloc anesthesia of the upper limb: study protocol randomized controlled trial. Trials. 2017 Jul 21;18(1):346. doi: 10.1186/s13063-017-2086-1.

  PMID: 28732521 DERIVED

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Pablo Echave, M.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)