Suprascapular Nerve Block Efficacy for Shoulder Surgery

NCT ID: NCT04364542

Last Updated: 2020-04-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-10

Study Completion Date

2021-08-30

Brief Summary

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This study evaluates the analgesia induced by suprascapular nerve block in comparison to interscalene nerve block in arthroscopic rotator cuff repairs. The experimental and the control group will receive the suprascapular nerve block and interscalene nerve block, respectively.

Detailed Description

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Peripheral nerve blocks are widely used for postsurgical analgesia. Interscalene nerve block provides a total brachial plexus motor and sensitive blockade while the suprascapular nerve block produces only a specific peripheral blockade.

The interscalene nerve block is the most frequently used anesthesia technique and requires a longer learning curve. Complications related to this technique may be more severe and frequent in comparison to other regional anesthesia techniques.

The suprascapular nerve block yields less adverse effects, discomfort and rebound effect as this technique does not completely block the upper limb motor function.

Conditions

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Shoulder Pain Postoperative Pain Rotator Cuff Tears Anesthesia Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups of patients. Randomization into groups SSNB or ISB as per randomization list, for a total of 98 patients
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Triple (Participant, Investigator, and Outcomes Assessor)

Study Groups

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Suprascapular nerve block (SSNB)

Single shot using the blind block technique with 10 ml 0.75% ropivacaine and arthroscopic portals infiltration with 5 ml 0.75% diluted in 15 ml of distilled water.

Group Type EXPERIMENTAL

Suprascapular nerve block

Intervention Type PROCEDURE

The patient lies supine in beach chair position with surgical drapes on. The anatomical landmarks are outlined and the infiltration spot is identified. The block is performed with 10 ml ropivacaine 0.75%.

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Conventional arthroscopic rotator cuff repair.

Interscalene Nerve Block (ISB)

Single shot using US-guided interscalene brachial plexus block with 15 ml 0.5% ropivacaine and arthroscopic portals infiltration with 5 ml 0.75% diluted in 15 ml of distilled water.

Group Type ACTIVE_COMPARATOR

Interscalene Nerve Block

Intervention Type PROCEDURE

The patient lies supine position with the head turned to the contralateral side to the block. A linear high-frequency ultrasound probe is used for identifying the roots of supraclavicular brachial plexus using the traceback technique. The block is performed with 15 ml ropivacaine 0.5%.

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Conventional arthroscopic rotator cuff repair.

Interventions

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Suprascapular nerve block

The patient lies supine in beach chair position with surgical drapes on. The anatomical landmarks are outlined and the infiltration spot is identified. The block is performed with 10 ml ropivacaine 0.75%.

Intervention Type PROCEDURE

Interscalene Nerve Block

The patient lies supine position with the head turned to the contralateral side to the block. A linear high-frequency ultrasound probe is used for identifying the roots of supraclavicular brachial plexus using the traceback technique. The block is performed with 15 ml ropivacaine 0.5%.

Intervention Type PROCEDURE

Arthroscopic rotator cuff repair

Conventional arthroscopic rotator cuff repair.

Intervention Type PROCEDURE

Other Intervention Names

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Interscalene Brachial Plexus Nerve Blockade

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 80 years old
* Confirmed rotator cuff tear by magnetic resonance imaging

Exclusion Criteria

* Irreparable cuff tears (retracted lesions to the glenoid rim and/or fourth grade fatty infiltration)
* Partial repair of cuff tears (immobile lesions)
* Rheumatic diseases
* Neck-related shoulder pain
* Glenohumeral instability or osteoarthritis
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ivan Simionato

OTHER

Sponsor Role lead

Responsible Party

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Ivan Simionato

Clinical Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marcelo F Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Locations

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Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Ivan F Simionato, MD

Role: CONTACT

+5551992077188

Rodrigo PG Barreto, PhD

Role: CONTACT

+5551985861181

Facility Contacts

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Rodrigo PG Barreto, PhD

Role: primary

+5551985861181

References

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Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.

Reference Type BACKGROUND
PMID: 16282408 (View on PubMed)

Lindberg MF, Grov EK, Gay CL, Rustoen T, Granheim TI, Amlie E, Lerdal A. Pain characteristics and self-rated health after elective orthopaedic surgery - a cross-sectional survey. J Clin Nurs. 2013 May;22(9-10):1242-53. doi: 10.1111/jocn.12149. Epub 2013 Mar 29.

Reference Type BACKGROUND
PMID: 23551432 (View on PubMed)

Desai N. Postoperative analgesia for shoulder surgery. Br J Hosp Med (Lond). 2017 Sep 2;78(9):511-515. doi: 10.12968/hmed.2017.78.9.511.

Reference Type BACKGROUND
PMID: 28898151 (View on PubMed)

Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.

Reference Type BACKGROUND
PMID: 28968280 (View on PubMed)

Vandepitte C, Gautier P, Xu D, Salviz EA, Hadzic A. Effective volume of ropivacaine 0.75% through a catheter required for interscalene brachial plexus blockade. Anesthesiology. 2013 Apr;118(4):863-7. doi: 10.1097/ALN.0b013e3182850dc7.

Reference Type BACKGROUND
PMID: 23353796 (View on PubMed)

Lee JJ, Kim DY, Hwang JT, Lee SS, Hwang SM, Kim GH, Jo YG. Effect of ultrasonographically guided axillary nerve block combined with suprascapular nerve block in arthroscopic rotator cuff repair: a randomized controlled trial. Arthroscopy. 2014 Aug;30(8):906-14. doi: 10.1016/j.arthro.2014.03.014. Epub 2014 May 29.

Reference Type BACKGROUND
PMID: 24880194 (View on PubMed)

Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.

Reference Type BACKGROUND
PMID: 31392721 (View on PubMed)

Other Identifiers

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ShoulderSurgeryGroupSCPA

Identifier Type: -

Identifier Source: org_study_id

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