NCT07831096

Brief Summary

Shoulder surgery performed in the outpatient setting can be associated with moderate to severe postoperative pain, especially during the first hours after surgery. Regional anesthesia is commonly used to improve postoperative pain control, reduce opioid use, and support early recovery and safe discharge. The interscalene block (ISB) is widely considered an effective regional anesthesia technique for shoulder surgery, but it may be associated with adverse effects such as diaphragmatic impairment, dyspnea, hoarseness, Horner syndrome, and prolonged upper limb motor block. The anterior suprascapular nerve block (SSNB-A) is a more selective regional anesthesia technique that may provide comparable postoperative analgesia with fewer block-related adverse effects. This prospective, randomized, single-blind, noninferiority trial compares SSNB-A with ISB in adult patients undergoing unilateral shoulder surgery in the outpatient setting. All participants receive general anesthesia and the same multimodal analgesic strategy. The primary objective is to determine whether SSNB-A is noninferior to ISB for postoperative pain control, assessed using the Numeric Rating Scale (NRS). Secondary outcomes include quality of recovery measured with the QoR-15 questionnaire, block-related adverse events, sensory and motor block characteristics, and the need for rescue analgesic medication.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress59%
Jan 2026Apr 2027

Study Start

First participant enrolled

January 16, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 9, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

Shoulder surgeryInterscalene blockAnterior suprascapular nerve blockRegional AnesthesiaOutpatient SurgeryPostoperative analgesiaQuality of recoveryNumeric Rating ScaleMultimodal Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity at 6 hours after surgery

    Postoperative pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary analysis compares NRS pain scores between the anterior suprascapular nerve block group and the interscalene block group to assess noninferiority.

    6 hours after surgery

Secondary Outcomes (5)

  • Postoperative Pain Intensity at Other Predefined Postoperative Time Points

    At post-anesthesia care unit arrival and at 12, 18, 24, 36, 48, and 72 hours after surgery

  • Quality of Recovery

    On postoperative day 0, postoperative day 1, postoperative day 2, postoperative day 3, and postoperative day 5

  • Incidence of Block-Related Adverse Events

    From block performance through postoperative day 0

  • Rescue Analgesic Consumption

    From post-anesthesia care unit arrival through postoperative day 5

  • Sensory and Motor Block Characteristics

    At 30 minutes after block performance, at post-anesthesia care unit arrival, and 6 hours after surgery

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

Participants randomized to this group receive an ultrasound-guided interscalene brachial plexus block before shoulder surgery, followed by standardized general anesthesia and the same multimodal postoperative analgesic protocol used in both study groups.

Procedure: Interscalene Nerve BlockDrug: Ropivacaine

Anterior Suprascapular Nerve Block

EXPERIMENTAL

Participants randomized to this group receive an ultrasound-guided anterior suprascapular nerve block before shoulder surgery, followed by standardized general anesthesia and the same multimodal postoperative analgesic protocol used in both study groups.

Procedure: Anterior suprascapular nerve blockDrug: Ropivacaine

Interventions

Participants receive an ultrasound-guided interscalene brachial plexus block before shoulder surgery using 10 mL of ropivacaina 0,5%, followed bu standardized general anesthesia and postoperative multimodal analgesia

Also known as: Ultrasound-guided interscalene block, ISB
Interscalene block

Participants receive an ultrasound-guided anterior suprascapular nerve block before shoulder surgery using 10 mL of ropivacaine 0,5%, followed by standardized general anesthesia and postoperative multimodal analgesia.

Also known as: SSNB-A, Ultrasound-guided anterior suprascapular nerve block
Anterior Suprascapular Nerve Block

Ropivacaine 0.5% is used as the local anesthetic for the assigned ultrasound-guided regional anesthesia procedure. Participants receive 10 mL of ropivacaine 0.5% either for interscalene brachial plexus block or for anterior suprascapular nerve block, according to randomized group allocation. The same drug concentration and volume are used in both study groups.

Also known as: Ropivacaine 0.5%
Anterior Suprascapular Nerve BlockInterscalene block

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years.
  • ASA physical status I, II, or III.
  • Scheduled for unilateral shoulder orthopedic surgery in the outpatient/day surgery setting under general anesthesia.
  • Surgical procedures may include long head of biceps tenotomy, biceps anchor repair, Bankart procedure, rotator cuff repair with or without biological membrane augmentation, subacromial decompression, acromioplasty, or acromioclavicular stabilization.
  • Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

  • Contraindication to regional anesthesia, including allergy to local anesthetics, infection at the injection site, bleeding diathesis, or other contraindications according to applicable clinical practice recommendations.
  • Allergy to paracetamol or to any drug used in the multimodal rescue analgesic strategy.
  • Known neuropathy or sensory/motor deficit in the surgical area or in the territory of innervation of the study blocks.
  • History of psychiatric or behavioral disorders that may interfere with study participation or outcome assessment.
  • Severe obesity, defined as body mass index (BMI) \> 40 kg/m2.
  • Severe chronic obstructive pulmonary disease, GOLD stage III-IV.
  • Pregnancy.
  • Known phrenic nerve palsy associated with diaphragmatic paralysis.
  • Chronic opioid use during the previous 3 months.
  • Severe chronic pain during the previous 3 months, defined as NRS \> 4.
  • Non-adherence to the postoperative analgesic protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Varese ASST SetteLaghi

Varese, Italy, 21100, Italy

RECRUITING

Related Publications (4)

  • Dogan AT, Cosarcan SK, Gurkan Y, Koyuncu O, Ercelen O, Demirhan M. Comparison of anterior suprascapular nerve block versus interscalane nerve block in terms of diaphragm paralysis in arthroscopic shoulder surgery: a prospective randomized clinical study. Acta Orthop Traumatol Turc. 2022 Nov;56(6):389-394. doi: 10.5152/j.aott.2022.22044.

    PMID: 36567542BACKGROUND
  • Lim YC, Koo ZK, Ho VW, Chang SS, Manohara S, Tong QJ. Randomized, controlled trial comparing respiratory and analgesic effects of interscalene, anterior suprascapular, and posterior suprascapular nerve blocks for arthroscopic shoulder surgery. Korean J Anesthesiol. 2020 Oct;73(5):408-416. doi: 10.4097/kja.20141. Epub 2020 Jul 16.

    PMID: 32668833BACKGROUND
  • White L, Reardon D, Davis K, Velli G, Bright M. Anterior suprascapular nerve block versus interscalene brachial plexus block for arthroscopic shoulder surgery: a systematic review and meta-analysis of randomized controlled trials. J Anesth. 2022 Feb;36(1):17-25. doi: 10.1007/s00540-021-03000-z. Epub 2021 Sep 17.

    PMID: 34533639BACKGROUND
  • Abdallah FW, Wijeysundera DN, Laupacis A, Brull R, Mocon A, Hussain N, Thorpe KE, Chan VWS. Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial. Anesthesiology. 2020 Apr;132(4):839-853. doi: 10.1097/ALN.0000000000003132.

    PMID: 32044802BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and postoperative outcome assessors are blinded to treatment allocation. The anesthesiologist performing the regional anesthesia technique is not blinded because the two blocks require different anatomical approaches. Postoperative data collection is performed by assessors unaware of grous assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized in a 1:1 ratioto receive either ultrasound-guided interscalene block or ultrasound-guided anterior suprascapular nerve block before shoulder surgery. The two groups are followed in parallel and receive the same general anesthesia and multimodal postoperative analgesic protocol.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 21, 2026

Study Start

January 16, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 21, 2026

Record last verified: 2026-09

Locations