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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04364542
Other study ID # ShoulderSurgeryGroupSCPA
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 10, 2020
Est. completion date August 30, 2021

Study information

Verified date April 2020
Source Shoulder Surgery Group, Santa Casa de Porto Alegre
Contact Ivan F Simionato, MD
Phone +5551992077188
Email simionato.md@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 98
Est. completion date August 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
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%.
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%.
Arthroscopic rotator cuff repair
Conventional arthroscopic rotator cuff repair.

Locations

Country Name City State
Brazil Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Ivan Simionato

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. Review. — View 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. Review. — View 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. — View Citation

Lindberg MF, Grov EK, Gay CL, Rustøen 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity: Numeric Pain Rating Scale Numeric Pain Rating Scale - no pain (0), unbearable pain (10) 1 hour after surgery
Primary Pain intensity: Numeric Pain Rating Scale Numeric Pain Rating Scale - no pain (0), unbearable pain (10) 24 hours after surgery
Primary Pain intensity: Numeric Pain Rating Scale Numeric Pain Rating Scale - no pain (0), unbearable pain (10) 48 hours after surgery
Primary Pain intensity: Numeric Pain Rating Scale Numeric Pain Rating Scale - no pain (0), unbearable pain (10) 72 hours after surgery
Secondary Opiate Consumption Total amount of narcotics consumed during the postoperative period measured in morphine equivalents (OME). Postoperative hours 1-72
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