Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block

Distal Radius Fractures Clinical Trial

Official title:

Prospective Randomized Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02208245
• Other study ID #: Infra Study
• Status: Active, not recruiting
• Phase: N/A
• First received: July 30, 2014
• Last updated: August 2, 2014
• Start date: February 2014
• Est. completion date: March 2015

Study information

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

Clinical Trial Summary

The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. To get the brachial plexus block, several routes can be used, including the axillary and infraclavicular approach.

Few studies have compared these techniques, considering the time to perform the block, the onset time and success rate, with conflicting results. Furthermore, there is little information in the literature comparing the length of postoperative analgesia provided by these techniques.

Therefore, the investigators designed this study in order to elucidate the differences between these two techniques to assist the anesthesiologist to choose the best of them in clinical practice.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age older than 18 years and less than 70 years

• consent informed signed by the patient

• candidates for surgical intervention of scaphoid fractures, distal radius fractures and wrist arthrodesis

• American Society of Anesthesiology physical status I, II and III

• body mass index (BMI) <35 kg / m².

Exclusion Criteria:

• cognitive impairment or active psychiatric condition

• infection at the puncture site

• bleeding disorders

• history of allergy to ropivacaine

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

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures
• Scaphoid Fractures
• Wrist Injuries
• Wrist Injury Arthrodesis

Intervention

Device:
• Ultrasound: Axillary block
Ultrasound guided axillary block
• Ultrasound: Infraclavicular block
Ultrasound guided infraclvicular block

Drug:
• Ropivacaine
20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Hospital Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-90, table of contents. — View Citation

Ferraro LH, Takeda A, dos Reis Falcão LF, Rezende AH, Sadatsune EJ, Tardelli MA. Determination of the minimum effective volume of 0.5% bupivacaine for ultrasound-guided axillary brachial plexus block. Braz J Anesthesiol. 2014 Jan-Feb;64(1):49-53. doi: 10.1016/j.bjane.2013.03.014. Epub 2013 Dec 2. — View Citation

Koscielniak-Nielsen ZJ, Frederiksen BS, Rasmussen H, Hesselbjerg L. A comparison of ultrasound-guided supraclavicular and infraclavicular blocks for upper extremity surgery. Acta Anaesthesiol Scand. 2009 May;53(5):620-6. doi: 10.1111/j.1399-6576.2009.01909.x. — 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

Ootaki C, Hayashi H, Amano M. Ultrasound-guided infraclavicular brachial plexus block: an alternative technique to anatomical landmark-guided approaches. Reg Anesth Pain Med. 2000 Nov-Dec;25(6):600-4. — View Citation

Sandhu NS, Capan LM. Ultrasound-guided infraclavicular brachial plexus block. Br J Anaesth. 2002 Aug;89(2):254-9. — View Citation

Song IA, Gil NS, Choi EY, Sim SE, Min SW, Ro YJ, Kim CS. Axillary approach versus the infraclavicular approach in ultrasound-guided brachial plexus block: comparison of anesthetic time. Korean J Anesthesiol. 2011 Jul;61(1):12-8. doi: 10.4097/kjae.2011.61.1.12. Epub 2011 Jul 21. — 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

Tran DQ, Russo G, Muñoz L, Zaouter C, Finlayson RJ. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular, and axillary brachial plexus blocks. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):366-71. doi: 10.1097/AAP.0b013e3181ac7d18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative analgesia	All patients will be contacted on the first postoperative day to tell the time of onset of pain postoperatively. The duration of postoperative analgesia is defined as the interval between the end of local anesthetic injection and the onset of postoperative pain reported by the patient.	first postoperative day	No
Secondary	local anesthetic pharmacokinetics	Venous blood samples will be taken from some patients through a cannula. The samples will be used for the determination of serum levels achieved after ropivacaine blockade. Samples will be taken every 15 minutes during the first hour, every 30 minutes during the second hour and 4 hours after the blockade. These samples will be analyzed using the technique of high performance liquid chromatography coupled with mass spectrometry.	During the procedure	Yes