SPENG Block Versus Suprascapular and Axillary Nerve Blocks for Pain After Shoulder Arthroscopy (SPENG-RCT)

August 12, 2026 updated by: Murat Kaykaç, Izmir City Hospital

Analgesic Efficacy of the Shoulder Posterior Pericapsular Nerve Group Block Versus Combined Posterior Suprascapular and Axillary Nerve Blocks for Shoulder Arthroscopy: A Randomized, Blinded, Non-Inferiority Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SPENG Block
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
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.
Other Names:
  • SPENG Block
Active Comparator: Posterior Suprascapular and Axillary Nerve Blocks
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
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.
Other Names:
  • Posterior Shoulder Block

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
Time Frame: From arrival in the post-anesthesia care unit through 24 hours after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Complete Dual-Target Sensory Block Success
Time Frame: 30 minutes after block completion
Cold sensation will be assessed over the posterior shoulder (suprascapular nerve territory) and lateral deltoid region (axillary nerve territory) using a 3-point scale: 0 = absent sensation, 1 = reduced sensation, and 2 = normal sensation. Suprascapular sensory component success will be defined as a reduction of at least one grade from baseline in the posterior shoulder region. Axillary sensory component success will be defined as a reduction of at least one grade from baseline in the lateral deltoid region. Complete dual-target sensory block success will require successful sensory blockade in both territories in the same participant.
30 minutes after block completion
Cumulative Opioid Consumption During the First 24 Postoperative Hours
Time Frame: From arrival in the post-anesthesia care unit through 24 hours after surgery
All rescue opioid analgesics administered during the first 24 postoperative hours will be recorded and converted to intravenous morphine-equivalent dose for comparison between groups.
From arrival in the post-anesthesia care unit through 24 hours after surgery
Time to First Rescue Analgesic
Time Frame: From block completion through 24 hours after surgery
Time from completion of the study block to the first administration of rescue analgesic medication for postoperative pain.
From block completion through 24 hours after surgery
Resting Numeric Rating Scale Pain Scores
Time Frame: On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
Resting pain intensity will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain).
On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
Numeric Rating Scale Pain Scores With Movement
Time Frame: On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
Pain intensity during standardized shoulder-related movement will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain), when clinically feasible.
On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
Anterior Shoulder Numeric Rating Scale Pain Score
Time Frame: At 8, 12, and 24 hours after surgery
Pain localized predominantly to the anterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
At 8, 12, and 24 hours after surgery
Posterior Shoulder Numeric Rating Scale Pain Score
Time Frame: At 8, 12, and 24 hours after surgery
Pain localized predominantly to the posterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
At 8, 12, and 24 hours after surgery
Proportion of Participants With Hemidiaphragmatic Paresis
Time Frame: 30 minutes after block completion
Diaphragmatic excursion will be assessed using M-mode ultrasonography. Hemidiaphragmatic paresis will be defined as diaphragmatic excursion 30 minutes after block completion falling to less than 25% of the participant's baseline excursion.
30 minutes after block completion
Change in Diaphragmatic Excursion From Baseline
Time Frame: Baseline and 30 minutes after block completion
Diaphragmatic excursion will be measured using M-mode ultrasonography as the difference in diaphragm position between resting expiration and deep inspiration. Three measurements will be obtained and averaged. Change from baseline will be evaluated after the block.
Baseline and 30 minutes after block completion
Shoulder Abduction Motor Strength
Time Frame: Baseline, 30 minutes after block completion, and 24 hours after surgery
Shoulder abduction strength will be evaluated using the Medical Research Council (MRC) scale ranging from 0 to 5, with higher scores indicating greater muscle strength.
Baseline, 30 minutes after block completion, and 24 hours after surgery
Proportion of Participants With Rebound Pain
Time Frame: During the first 24 postoperative hours
Rebound pain will be defined as an increase from an NRS pain score of 3 or lower at the preceding assessment to an NRS score of 7 or higher at the subsequent assessment.
During the first 24 postoperative hours
Quality of Recovery-15 Score
Time Frame: 24 hours after surgery
Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
24 hours after surgery
Patient Satisfaction With Perioperative Analgesia
Time Frame: 24 hours after surgery
Overall satisfaction with perioperative analgesia will be rated on an 11-point scale from 0 (completely dissatisfied) to 10 (completely satisfied).
24 hours after surgery
Number of Participants With Block-Related Complications
Time Frame: From block performance through postoperative day 7
Participants will be assessed for block-related adverse events including hematoma, infection, persistent paresthesia, persistent weakness, and other clinically suspected complications.
From block performance through postoperative day 7
Block Performance Time
Time Frame: Periprocedural
Time required to perform the allocated regional anesthesia technique, measured in seconds from the first contact of the ultrasound transducer with the skin until removal of the block needle after completion of local anesthetic injection.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Murat KAYKAC, MD, İzmir City Hospital
  • Study Director: Derya ARSLAN YURTLU, Professor, İzmir City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPENG-RCT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning after publication of the primary study results and available for 5 years thereafter.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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