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Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

NCT ID: NCT03224884

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2017-10-25

Brief Summary

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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

Detailed Description

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Conditions

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Pain, Postoperative Shoulder Pain Surgical Procedure, Unspecified Diaphragmatic Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Interscalene block

Patients randomized to receive an interscalene block .

Group Type ACTIVE_COMPARATOR

Interscalene block

Intervention Type PROCEDURE

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.

Supraclavicular block

Patients randomized to receive a supraclavicular block.

Group Type EXPERIMENTAL

Supraclavicular block

Intervention Type PROCEDURE

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).

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Julian Aliste

Clinical Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clinico Universidad de Chile

Santiago, Metropolitan, Chile

Site Status

Countries

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Chile

References

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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.

Reference Type RESULT
PMID: 19282714 (View on PubMed)

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.

Reference Type RESULT
PMID: 2006740 (View on PubMed)

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.

Reference Type RESULT
PMID: 26448030 (View on PubMed)

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.

Reference Type RESULT
PMID: 27941477 (View on PubMed)

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.

Reference Type RESULT
PMID: 19916254 (View on PubMed)

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.

Reference Type RESULT
PMID: 20975470 (View on PubMed)

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.

Reference Type RESULT
PMID: 21568985 (View on PubMed)

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.

Reference Type RESULT
PMID: 16331304 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29630033 (View on PubMed)

Other Identifiers

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888/17

Identifier Type: -

Identifier Source: org_study_id