Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block

Shoulder Injury Clinical Trial

— ISBvsICB-SSB  

Official title:

A Randomized Comparison Between Interscalene Brachial Plexus Block and Combined Infraclavicular Brachial Plexus Block-Suprascapular Nerve Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993939
• Other study ID #: 853/16
• Status: Completed
• Phase: N/A
• First received: December 12, 2016
• Last updated: May 2, 2017
• Start date: December 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may not be tolerated in patients with chronic pulmonary disease.

This RCT will compare the classic Interscalene block with combined infraclavicular block plus suprascapular nerve block in patients going for arthroscopic shoulder surgery.

Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.

Description:

PATIENT RECRUITMENT

With the approval of the Ethics Committee of Hospital Clinico Universidad de Chile, 40 patients undergoing arthroscopic shoulder surgery will be recruited. Enrollment will be carried out by an investigator not involved in patient care. Patients' confidentiality will be protected.

STUDY PROTOCOL: GENERAL

All blocks will be performed by one of the coauthors and conducted preoperatively in an induction room. Sedation (2 mg midazolam and 50 μg fentanyl) will be provided for patient comfort.

STUDY PROTOCOL: PERFORMANCE OF THE BLOCK

Both study groups will receive an ultrasound-guided superficial cervical plexus block.

In the ICB-SSB group, suprascapular nerve blocks will be carried out using a previously described technique. For infraclavicular brachial plexus blocks, 20 mL of levobupivacaine 0.25% with epinephrine 5 µg/mL will be injected dorsal to the axillary artery, medial to the coracoid process.

In the ISB group, block will carried out using a previously described technique: 20 mL of levobupivacaine 0.25% with epinephrine 5 µg/mL will be deposited under the prevertebral fascial between the C5 and C6 roots.

STUDY PROTOCOL: GENERAL ANESTHESIA

All patients will undergo standardized general anesthesia

STUDY PROTOCOL: POSTOPERATIVE ANALGESIA

In the Recovery Room, all patients will receive acetaminophen (usual dose…) and ketoprofen (usual dose…) as well as patient controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (usual dise…), celecoxib (usual dose…) as well and patient controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).

STUDY PROTOCOL: OUTCOME MEASUREMENTS

The primary outcome will be the pain score in the PACU at 30 30 minutes using a sensorimotor composite scale:

Performance time, sensorimotorSensory function, Onset time

The blinded investigator will also assess the presence of hemidiaphragmatic block at 30 minutes. A 2-6 MHz curvilinear US probe (Sonosite M-Turbo, SonoSite Inc, Bothell, WA, USA) and the M-mode will be employed in all subjects; the liver and spleen will serve as acoustic windows on the right and left side, respectively. Patients will be scanned along the anterior axillary line and the US probe, angled cranially

POTENTIAL BENEFITS OF THE STUDY This study will allow us to determine if ICB-SSB constitutes a viable alternative to ISB.

POTENTIAL SIDE EFFECTS OF THE STUDY Participation in this protocol will not put patients at higher risk for complications since ISB and ICB-SSB are commonly used to provide analgesia for shoulder surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age between 18 and 75 years

• American Society of Anesthesiologists classification 1-3

• body mass index between 20 and 30

Exclusion Criteria:

• adults who are unable to give their own consent

• pre-existing neuropathy (assessed by history and physical examination)

• coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets = 100, International Normalized Ratio = 1.4 or prothrombin time = 50)

• obstructive or restrictive pulmonary disease (assessed by history and physical examination)

• renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine = 100)

• hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases = 100)

• allergy to local anesthetics (LAs)

• pregnancy

• prior surgery in the neck, infraclavicular region or suprascapular fossa

• chronic pain syndromes requiring opioid intake at home

Related Conditions & MeSH terms

• Shoulder Injury

Intervention

Procedure:
• Interscalene block
Ultrasound guided single shot block above the clavicle
• Infraclavicular-suprascapular block
Combined block of nerves far away from phrenic nerve

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad de Chile	Santiago	Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (10)

Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0. Review. — View Citation

Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct; — View Citation

Flohr-Madsen S, Ytrebø LM, Valen K, Wilsgaard T, Klaastad Ø. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade. Anaesthesia. 2016 Aug — View Citation

Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. Epub 2005 Dec 6. — View Citation

Martínez J, Sala-Blanch X, Ramos I, Gomar C. Combined infraclavicular plexus block with suprascapular nerve block for humeral head surgery in a patient with respiratory failure: an alternative approach. Anesthesiology. 2003 Mar;98(3):784-5. — View Citation

Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb. Review. Er — View Citation

Spence BC, Beach ML, Gallagher JD, Sites BD. Ultrasound-guided interscalene blocks: understanding where to inject the local anaesthetic. Anaesthesia. 2011 Jun;66(6):509-14. doi: 10.1111/j.1365-2044.2011.06712.x. — View Citation

Tran DQ, Bertini P, Zaouter C, Muñoz 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.0b013e — View Citation

Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):539-43. doi: 10.1097/AAP.0b013e3181faa11c. — View Citation

Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static Pain using numeric scale 0-10		30 minutes after arrival to PACU
Secondary	Static Pain using numeric scale 0-10		12 hrs after arrival to PACU
Secondary	Diaphragm paralysis incidence		30 minutes after block
Secondary	Static Pain using numeric scale 0-10		24 hrs