NCT04364542

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

May 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

March 11, 2020

Last Update Submit

April 27, 2020

Conditions

Shoulder PainPostoperative PainRotator Cuff TearsAnesthesiaAnesthesia, Local

Keywords

Shoulder surgeryPainBrachial plexus blockageAnesthesiaInterscalene blockageOpioid

Outcome Measures

Primary Outcomes (4)

  • Pain intensity: Numeric Pain Rating Scale

    Numeric Pain Rating Scale - no pain (0), unbearable pain (10)

    1 hour after surgery

  • Pain intensity: Numeric Pain Rating Scale

    Numeric Pain Rating Scale - no pain (0), unbearable pain (10)

    24 hours after surgery

  • Pain intensity: Numeric Pain Rating Scale

    Numeric Pain Rating Scale - no pain (0), unbearable pain (10)

    48 hours after surgery

  • Pain intensity: Numeric Pain Rating Scale

    Numeric Pain Rating Scale - no pain (0), unbearable pain (10)

    72 hours after surgery

Secondary Outcomes (1)

  • Opiate Consumption

    Postoperative hours 1-72

Study Arms (2)

Suprascapular nerve block (SSNB)

EXPERIMENTAL

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.

Procedure: Suprascapular nerve blockProcedure: Arthroscopic rotator cuff repair

Interscalene Nerve Block (ISB)

ACTIVE COMPARATOR

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.

Procedure: Interscalene Nerve BlockProcedure: Arthroscopic rotator cuff repair

Interventions

Suprascapular nerve blockPROCEDURE

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%.

Suprascapular nerve block (SSNB)
Interscalene Nerve BlockPROCEDURE

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%.

Also known as: Interscalene Brachial Plexus Nerve Blockade
Interscalene Nerve Block (ISB)
Arthroscopic rotator cuff repairPROCEDURE

Conventional arthroscopic rotator cuff repair.

Interscalene Nerve Block (ISB)Suprascapular nerve block (SSNB)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035072, Brazil

Location

Related Publications (7)

  • 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.

    PMID: 16282408BACKGROUND

  • 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.

    PMID: 23551432BACKGROUND

  • 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.

    PMID: 28898151BACKGROUND

  • 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.

    PMID: 28968280BACKGROUND

  • 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.

    PMID: 23353796BACKGROUND

  • 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.

    PMID: 24880194BACKGROUND

  • 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.

    PMID: 31392721BACKGROUND

MeSH Terms

Conditions

Shoulder PainPain, PostoperativeRotator Cuff InjuriesPain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesRuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Marcelo F Silva, PhD

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan F Simionato, MD

CONTACT

+5551992077188simionato.md@gmail.com

Rodrigo PG Barreto, PhD

CONTACT

+5551985861181rodrigopyy@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, Investigator, and Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups of patients. Randomization into groups SSNB or ISB as per randomization list, for a total of 98 patients
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

March 11, 2020

First Posted

April 28, 2020

Study Start

May 10, 2020

Primary Completion

June 30, 2021

Study Completion

August 30, 2021

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)