NCT07762417

Brief Summary

This prospective, randomized, patient- and assessor-blinded, single-center non-inferiority trial will compare the analgesic efficacy of the Shoulder Posterior Pericapsular Nerve Group (SPENG) block with combined posterior suprascapular and axillary nerve blocks in adults undergoing elective shoulder arthroscopy under general anesthesia. Both groups will receive the same total volume and concentration of local anesthetic. The primary outcome will be the highest resting Numeric Rating Scale pain score recorded during the first 24 postoperative hours. Secondary outcomes will include block performance time, sensory block success in suprascapular and axillary nerve territories, opioid consumption, time to rescue analgesia, motor function, diaphragmatic function, postoperative recovery quality, patient satisfaction, and block-related complications.

Trial Health

65
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
8mo left

Started Nov 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 9, 2026

Last Update Submit

August 12, 2026

Conditions

Keywords

Diaphragm-sparing blockPostoperative analgesiaRegional anesthesiaAxillary nerve blockSuprascapular nerve blockShoulder arthroscopyShoulder Posterior Pericapsular Nerve Group blockSPENG block

Outcome Measures

Primary Outcomes (1)

  • Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours

    Resting postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). For each participant, the highest resting NRS score recorded during the first 24 postoperative hours will be used as the primary outcome. Scheduled assessments will be performed on arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery. Resting NRS scores obtained immediately before rescue analgesic administration outside these scheduled assessments will also be included when determining the highest value.

    From arrival in the post-anesthesia care unit through 24 hours after surgery

Secondary Outcomes (15)

  • Block Performance Time

    Periprocedural

  • Proportion of Participants With Complete Dual-Target Sensory Block Success

    30 minutes after block completion

  • Cumulative Opioid Consumption During the First 24 Postoperative Hours

    From arrival in the post-anesthesia care unit through 24 hours after surgery

  • Time to First Rescue Analgesic

    From block completion through 24 hours after surgery

  • Resting Numeric Rating Scale Pain Scores

    On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery

  • +10 more secondary outcomes

Study Arms (2)

SPENG Block

EXPERIMENTAL

Participants assigned to this group will receive an ultrasound-guided Shoulder Posterior Pericapsular Nerve Group (SPENG) block before general anesthesia for shoulder arthroscopy. A total of 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered as a single injection between the posterior glenoid rim and the deep surface of the infraspinatus muscle.

Procedure: Shoulder Posterior Pericapsular Nerve Group (SPENG) Block

Posterior Suprascapular and Axillary Nerve Blocks

ACTIVE COMPARATOR

Participants assigned to this group will receive ultrasound-guided posterior suprascapular and axillary nerve blocks before general anesthesia for shoulder arthroscopy. A total of 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered, consisting of 10 mL for the posterior suprascapular nerve block and 10 mL for the axillary nerve block.

Procedure: Combined Posterior Suprascapular and Axillary Nerve Blocks

Interventions

An ultrasound-guided single-injection posterior pericapsular block. With the participant in the lateral decubitus position and the operative shoulder uppermost, a high-frequency linear ultrasound transducer will be placed transversely immediately inferior to the posterior acromion. After identification of the humeral head, articular cartilage, infraspinatus muscle, and posterior glenoid rim, a block needle will be advanced in-plane in a medial-to-lateral direction. The needle tip will be positioned between the posterior glenoid rim and the deep surface of the infraspinatus muscle, and 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be injected.

Also known as: SPENG Block
SPENG Block

wo ultrasound-guided nerve blocks will be performed. For the posterior suprascapular nerve block, the suprascapular nerve will be identified in the suprascapular notch region beneath the supraspinatus muscle, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered. For the axillary nerve block, the posterior humeral circumflex artery will be identified using color Doppler in the quadrilateral space, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered adjacent to the axillary nerve.

Also known as: Posterior Shoulder Block
Posterior Suprascapular and Axillary Nerve Blocks

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 70 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled to undergo elective shoulder arthroscopy under general anesthesia
  • Able to understand the Numeric Rating Scale for pain assessment
  • Able and willing to provide written informed consent

You may not qualify if:

  • Known allergy or hypersensitivity to local anesthetics used in the study
  • Infection at the planned block injection site
  • Coagulopathy or ongoing anticoagulant therapy that cannot be appropriately interrupted for peripheral nerve block
  • Pre-existing neurological deficit affecting the operative upper extremity
  • Moderate or severe pulmonary disease
  • Known diaphragmatic dysfunction
  • Chronic opioid use
  • Chronic pain syndrome
  • Body mass index greater than 35 kg/m²
  • Pregnancy or breastfeeding
  • Inability to understand or reliably report Numeric Rating Scale pain scores
  • Inadequate sonographic window preventing safe performance of the allocated block technique before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Murat KAYKAC, MD

    Izmir City Hospital

    PRINCIPAL INVESTIGATOR
  • Derya ARSLAN YURTLU, Professor

    Izmir City Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors will be blinded to treatment allocation. Before block placement, participants will receive intravenous midazolam. Both groups will be positioned similarly, and identical dressings will be applied over the posterior shoulder and suprascapular regions after block completion to conceal the injection sites. Outcome assessments will be performed by an investigator who is not involved in block administration and is unaware of treatment allocation. The physician performing the block cannot be blinded because of the procedural differences between the interventions and will not participate in outcome assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either a single-injection Shoulder Posterior Pericapsular Nerve Group (SPENG) block or combined posterior suprascapular and axillary nerve blocks before elective shoulder arthroscopy. Both groups will receive the same total volume, concentration, and dose of local anesthetic.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist

Study Record Dates

First Submitted

August 9, 2026

First Posted

August 13, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request to the principal investigator. Data will be shared after publication of the main study results, subject to approval of the proposed use and compliance with applicable ethical and institutional data-protection requirements.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning after publication of the primary study results and available for 5 years thereafter.
Access Criteria
Requests from qualified researchers with a scientifically sound proposal will be considered by the principal investigator. Data will be provided in de-identified form for approved research purposes and subject to applicable institutional and ethical requirements.