Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

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

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 will compare ultrasound-guided interscalene block (ISB) and supraclavicular block 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 supraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Shoulder Pain; Surgical Procedure, Unspecified; Diaphragmatic Paralysis
• Intervention / Treatment: Procedure: Interscalene block; Procedure: Supraclavicular block

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitan
    • Santiago, Metropolitan, Chile, 8380456
      • Hospital Clinico Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 supraclavicular fossa
• Chronic pain syndromes requiring opioid intake at home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interscalene block; Patients randomized to receive an interscalene block .	Procedure: Interscalene block; Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.
Experimental: Supraclavicular block; Patients randomized to receive a supraclavicular block.	Procedure: Supraclavicular block; Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the "corner pocket" followed by 17 mL posterolateral to the brachial plexus).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static pain at 30 minutes after arrival in the PACU	Evaluated with a NRS from 0 to 10.	30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Chile

Publications and helpful links

General Publications

• 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. Erratum In: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407.
• 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. doi: 10.1213/00000539-199104000-00014.
• 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.
• 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.
• 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. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.
• Ryu T, Kil BT, Kim JH. Comparison Between Ultrasound-Guided Supraclavicular and Interscalene Brachial Plexus Blocks in Patients Undergoing Arthroscopic Shoulder Surgery: A Prospective, Randomized, Parallel Study. Medicine (Baltimore). 2015 Oct;94(40):e1726. doi: 10.1097/MD.0000000000001726.
• Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
• Renes SH, Spoormans HH, Gielen MJ, Rettig HC, van Geffen GJ. Hemidiaphragmatic paresis can be avoided in ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):595-9. doi: 10.1097/aap.0b013e3181bfbd83.
• Aliste J, Bravo D, Fernandez D, Layera S, Finlayson RJ, Tran DQ. A Randomized Comparison Between Interscalene and Small-Volume Supraclavicular Blocks for Arthroscopic Shoulder Surgery. Reg Anesth Pain Med. 2018 Aug;43(6):590-595. doi: 10.1097/AAP.0000000000000767.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): October 25, 2017
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 11, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Respiratory Insufficiency; Pain, Postoperative; Shoulder Pain; Paralysis; Respiratory Paralysis
• Other Study ID Numbers: 888/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No