Clinical trial NCT04364542: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Postoperative Pain
Rotator Cuff Tears
Anesthesia
Anesthesia, Local
Keywords: Shoulder surgery
Pain
Brachial plexus blockage
Anesthesia
Interscalene blockage
Opioid
Lead sponsor: Shoulder Surgery Group, Santa Casa de Porto Alegre
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of patients. Randomization into groups SSNB or ISB as per randomization list, for a total of 98 patients
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity: Numeric Pain Rating Scale
timeFrame: 1 hour after surgery
measure: Pain intensity: Numeric Pain Rating Scale
timeFrame: 24 hours after surgery
measure: Pain intensity: Numeric Pain Rating Scale
timeFrame: 48 hours after surgery
measure: Pain intensity: Numeric Pain Rating Scale
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Opiate Consumption
timeFrame: Postoperative hours 1-72
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Marcelo F Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.