Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

Pain, Postoperative Clinical Trial

Official title:

A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411343
• Other study ID #: 889/17
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: July 6, 2018

Study information

• Verified date: July 2018
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery.

The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing arthroscopic shoulder surgery

• American Society of Anesthesiologists classification 1-3

• Body mass index between 20 and 35

Exclusion Criteria:

• Adults who are unable to give their own consent

• Pre-existing neuropathy

• Coagulopathy

• Obstructive or restrictive pulmonary disease

• Renal failure

• Hepatic failure

• Allergy to local anesthetics

• Pregnancy

• Prior surgery in the corresponding side of the neck or infraclavicular fossa

• Chronic pain syndromes requiring opioid intake at home

Related Conditions & MeSH terms

• Diaphragmatic Paralysis
• Pain, Postoperative
• Paralysis
• Respiratory Paralysis
• Shoulder Pain
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Interscalene Block
Injection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus.
• Costoclavicular Infraclavicular Block
Ultrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space.

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (11)

Aliste J, Bravo D, Finlayson RJ, Tran DQ. A randomized comparison between interscalene and combined infraclavicular-suprascapular blocks for arthroscopic shoulder surgery. Can J Anaesth. 2018 Mar;65(3):280-287. doi: 10.1007/s12630-017-1048-0. Epub 2017 Dec 19. — 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;71(8):938-47. doi: 10.1111/anae.13504. — View Citation

Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. — View Citation

Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15. — 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. Erratum in: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407. — 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

Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16. — 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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static pain at 30 minutes after arrival in the PACU	Evaluated with a NRS from 0 to 10	30 minutes
Secondary	Static pain at 60 minutes after arrival in the PACU	Evaluated with a NRS from 0 to 10	60 minutes
Secondary	Postoperative static pain at 2 hours	Evaluated with a NRS from 0 to 10	2 hours
Secondary	Postoperative static pain at 3 hours	Evaluated with a NRS from 0 to 10	3 hours
Secondary	Postoperative static pain at 6 hours	Evaluated with a NRS from 0 to 10	6 hours
Secondary	Postoperative static pain at 12 hours	Evaluated with a NRS from 0 to 10	12 hours
Secondary	Postoperative static pain at 24 hours	Evaluated with a NRS from 0 to 10	24 hours
Secondary	Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block	Ultrasound diagnosed HDP	30 minutes post injection
Secondary	Incidence of HDP at 30 minutes after arrival to PACU	Ultrasound diagnosed HDP	30 minutes after arrival to the PACU
Secondary	Block performance time	Time from skin disinfection until the end of local anesthetic injection	1 hour before surgery
Secondary	Sensory and Motor block score	Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score	30 minutes post injection
Secondary	Incidence of complete block	Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection	30 minutes post injection
Secondary	Procedural pain during blocks	Evaluated with a NRS from 0 to 10	1 hour before surgery
Secondary	Onset time	Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points	1 hour before surgery
Secondary	Intraoperative opioid requirements	Total amount of fentanyl required during general anesthesia	Intraoperative period
Secondary	Surgical duration	Time between skin incision and closure	Intraoperative period
Secondary	Postoperative opioid consumption	Total amount of morphine required during the first 24 hours after surgery	24 hours after surgery
Secondary	Patient satisfaction	Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)	24 hours after surgery
Secondary	Block- and opioid-related side effects	Incidence of side effects	1 week