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Suprascapular Nerve Block Efficacy for Shoulder Surgery

Primary Purpose

Shoulder Pain, Postoperative Pain, Rotator Cuff Tears

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Suprascapular nerve block
Interscalene Nerve Block
Arthroscopic rotator cuff repair
Sponsored by
Ivan Simionato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder surgery, Pain, Brachial plexus blockage, Anesthesia, Interscalene blockage, Opioid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irmandade Santa Casa de Misericordia de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Suprascapular nerve block (SSNB)

Interscalene Nerve Block (ISB)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Opiate Consumption
Total amount of narcotics consumed during the postoperative period measured in morphine equivalents (OME).

Full Information

First Posted
March 11, 2020
Last Updated
April 27, 2020
Sponsor
Ivan Simionato
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1. Study Identification

Unique Protocol Identification Number
NCT04364542
Brief Title
Suprascapular Nerve Block Efficacy for Shoulder Surgery
Official Title
Suprascapular Nerve Block Efficacy for Arthroscopic Rotator Cuff Repair: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ivan Simionato

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Postoperative Pain, Rotator Cuff Tears, Anesthesia, Anesthesia, Local
Keywords
Shoulder surgery, Pain, Brachial plexus blockage, Anesthesia, Interscalene blockage, Opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups of patients. Randomization into groups SSNB or ISB as per randomization list, for a total of 98 patients
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple (Participant, Investigator, and Outcomes Assessor)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suprascapular nerve block (SSNB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Interscalene Nerve Block (ISB)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Suprascapular nerve block
Intervention Description
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
Intervention Name(s)
Interscalene Nerve Block
Other Intervention Name(s)
Interscalene Brachial Plexus Nerve Blockade
Intervention Description
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
Intervention Name(s)
Arthroscopic rotator cuff repair
Intervention Description
Conventional arthroscopic rotator cuff repair.
Primary Outcome Measure Information:
Title
Pain intensity: Numeric Pain Rating Scale
Description
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Time Frame
1 hour after surgery
Title
Pain intensity: Numeric Pain Rating Scale
Description
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Time Frame
24 hours after surgery
Title
Pain intensity: Numeric Pain Rating Scale
Description
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Time Frame
48 hours after surgery
Title
Pain intensity: Numeric Pain Rating Scale
Description
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Time Frame
72 hours after surgery
Secondary Outcome Measure Information:
Title
Opiate Consumption
Description
Total amount of narcotics consumed during the postoperative period measured in morphine equivalents (OME).
Time Frame
Postoperative hours 1-72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan F Simionato, MD
Phone
+5551992077188
Email
simionato.md@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo PG Barreto, PhD
Phone
+5551985861181
Email
rodrigopyy@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo F Silva, PhD
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035072
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo PG Barreto, PhD
Phone
+5551985861181
Email
rodrigopyy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16282408
Citation
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.
Results Reference
background
PubMed Identifier
23551432
Citation
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.
Results Reference
background
PubMed Identifier
28898151
Citation
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.
Results Reference
background
PubMed Identifier
28968280
Citation
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.
Results Reference
background
PubMed Identifier
23353796
Citation
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.
Results Reference
background
PubMed Identifier
24880194
Citation
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.
Results Reference
background
PubMed Identifier
31392721
Citation
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.
Results Reference
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Suprascapular Nerve Block Efficacy for Shoulder Surgery

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