Three Techniques for Ultrasound Guided Axillary Brachial Plexus Block

Hand Surgery Clinical Trial

Official title:

Prospective Randomized Study of Three Different Techniques for Ultrasound Guided Axillary Brachial Plexus Block

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02073383
• Other study ID #: FUSaoPaulo - USG Guided Block
• Status: Active, not recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: February 25, 2014
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: February 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques most commonly used to obtain regional anesthesia of the upper limbs, being performed by anesthesia of the terminal branches of the brachial plexus, which would be the ulnar, median, radial and musculocutaneous nerves. With the aid of ultrasound , two techniques can be used to perform the BPVA . The first , known as multiple puncture technique , the local anesthetic is deposited around each nerve that want to block . This technique is most commonly used to perform the BPVA . The second technique , known as 2 injections , local anesthetic is deposited below the axillary artery and around the musculocutaneous nerve . This technique has been proposed to try to reduce the execution time of anesthesia . Studies actually show that the technique of 2 injections showed less time to perform the block, with the same success rate. However, the technique of 2 injections showed a longer latency and higher rate of vascular puncture . (14) In order to perform a procedure with shorter execution time , without changing the latency, success rate and ensuring patient safety , the investigators designed this protocol to evaluate three techniques for performing the ultrasound- guided axillary brachial plexus block.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 313
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Informed consent signed by the patient (IC)

• Indication for brachial plexus block for anesthesia and analgesia in candidates for hand surgical procedures

• ASA physical status I, II or III according to the American Association of Anesthesiology.

Exclusion Criteria:

• Cognitive impairment or psychiatric disease

• Active infection condition at the puncture site of the block

• Bleeding disorders

• History of allergy to bupivacaine.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand Surgery

Intervention

Procedure:
• Axillary brachial plexus block

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (15)

Bernucci F, Gonzalez AP, Finlayson RJ, Tran DQ. A prospective, randomized comparison between perivascular and perineural ultrasound-guided axillary brachial plexus block. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):473-7. doi: 10.1097/AAP.0b013e3182576b6f. — View Citation

Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. Epub 2007 May 3. — View Citation

DE JONG RH. Axillary block of the brachial plexus. Anesthesiology. 1961 Mar-Apr;22:215-25. — View Citation

Fredrickson MJ, Ball CM, Dalgleish AJ, Stewart AW, Short TG. A prospective randomized comparison of ultrasound and neurostimulation as needle end points for interscalene catheter placement. Anesth Analg. 2009 May;108(5):1695-700. doi: 10.1213/ane.0b013e31819c29b8. — View Citation

Gautier P, Vandepitte C, Ramquet C, DeCoopman M, Xu D, Hadzic A. The minimum effective anesthetic volume of 0.75% ropivacaine in ultrasound-guided interscalene brachial plexus block. Anesth Analg. 2011 Oct;113(4):951-5. doi: 10.1213/ANE.0b013e31822b876f. Epub 2011 Aug 4. — View Citation

Groban L. Central nervous system and cardiac effects from long-acting amide local anesthetic toxicity in the intact animal model. Reg Anesth Pain Med. 2003 Jan-Feb;28(1):3-11. Review. — View Citation

Imasogie N, Ganapathy S, Singh S, Armstrong K, Armstrong P. A prospective, randomized, double-blind comparison of ultrasound-guided axillary brachial plexus blocks using 2 versus 4 injections. Anesth Analg. 2010 Apr 1;110(4):1222-6. doi: 10.1213/ANE.0b013e3181cb6791. Epub 2010 Feb 8. — View Citation

Klaastad Ø, Smedby O, Thompson GE, Tillung T, Hol PK, Røtnes JS, Brodal P, Breivik H, Hetland KR, Fosse ET. Distribution of local anesthetic in axillary brachial plexus block: a clinical and magnetic resonance imaging study. Anesthesiology. 2002 Jun;96(6):1315-24. — View Citation

Marhofer P, Schrögendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. — View Citation

Mather LE, Copeland SE, Ladd LA. Acute toxicity of local anesthetics: underlying pharmacokinetic and pharmacodynamic concepts. Reg Anesth Pain Med. 2005 Nov-Dec;30(6):553-66. Review. — View Citation

Ponrouch M, Bouic N, Bringuier S, Biboulet P, Choquet O, Kassim M, Bernard N, Capdevila X. Estimation and pharmacodynamic consequences of the minimum effective anesthetic volumes for median and ulnar nerve blocks: a randomized, double-blind, controlled comparison between ultrasound and nerve stimulation guidance. Anesth Analg. 2010 Oct;111(4):1059-64. doi: 10.1213/ANE.0b013e3181eb6372. Epub 2010 Aug 12. — View Citation

Renes SH, van Geffen GJ, Rettig HC, Gielen MJ, Scheffer GJ. Minimum effective volume of local anesthetic for shoulder analgesia by ultrasound-guided block at root C7 with assessment of pulmonary function. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):529-34. doi: 10.1097/AAP.0b013e3181fa1190. — View Citation

Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4. — View Citation

Thompson GE, Rorie DK. Functional anatomy of the brachial plexus sheaths. Anesthesiology. 1983 Aug;59(2):117-22. — View Citation

Vester-Andersen T, Christiansen C, Sørensen M, Kaalund-Jørgensen HO, Saugbjerg P, Schultz-Møller K. Perivascular axillary block II: influence of injected volume of local anaesthetic on neural blockade. Acta Anaesthesiol Scand. 1983 Apr;27(2):95-8. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is to compare the efficacy of the three different techniques for ultrasound guided axillary brachial plexus block	The brachial plexus block is performed through the axilla , with the aid of ultrasound and a peripheral nerve stimulator with the patient in the supine position. The needle that will be used is 22G x 50 mm . After disinfection and skin antisepsis with chlorhexidine , tha puncture site will be infiltrated with 1% lidocaine . Furthermore, musculocutaneous nerve will be blockade with 10 ml of 0.375% bupivacaine for all patients. Patients will be divided into three groups : Group A: 30 ml of 0.375% bupivacaine will be injected around the artery . If this were a clock, would deposit 7,5 ml of anesthetic in positions 0, 3, 6 and 9 .; Group 2 injections : 30 ml of bupivacaine 0.375 % below the artery will be injected in the 6 o'clock position .; Group M : 10 ml of bupivacaine 0.375 % will be injected	The primary outcome will be measured at the same day of the procedure.	Yes
Secondary	Block Latency	Latency time of the blockade , defined as the time between the end of injection of local anesthetic will be noted.	30 minutes	No