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Not yet recruiting NCT07486349

Shoulder Pericapsular Block Versus Interscalene Block in Arthroscopic Shoulder Surgery

No phase Interventional Hemidiaphragmatic Paralysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interscalene Nerve Block, shoulder pericapsular nerve group block.
Who it may be relevant to
Registry conditions: Hemidiaphragmatic Paralysis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Ultrasound-Guided Interscalene Block Versus Shoulder Pericapsular Nerve Group (PENG) Block for Hemidiaphragmatic Paralysis in Elective Shoulder Surgery: A Randomized Controlled Trial

Overview

This randomized controlled trial aims to compare the incidence of hemidiaphragmatic paralysis (HDP) following ultrasound-guided interscalene block (ISB) versus shoulder pericapsular nerve group (PENG) block in patients undergoing elective shoulder surgery under general anesthesia. The primary objective is to determine whether the shoulder PENG block reduces the incidence of HDP compared with conventional intrafascial ISB. HDP will be assessed using ultrasound measurement of diaphragmatic excursion 30 minutes after block performance

Detailed description

Interscalene block is widely used for shoulder surgery but is frequently associated with ipsilateral hemidiaphragmatic paralysis due to phrenic nerve involvement. The shoulder PENG block is a more distal pericapsular technique targeting articular branches and may reduce diaphragmatic impairment.

This prospective, parallel-group, randomized controlled trial will enroll 68 adult patients scheduled for elective shoulder surgery. Participants will be randomly assigned (1:1) to receive either ultrasound-guided intrafascial interscalene block or ultrasound-guided shoulder PENG block.

Both groups will receive 15 mL of 0.25% bupivacaine (total dose 37.5 mg). Diaphragmatic excursion will be measured at baseline and 30 minutes after block performance using M-mode ultrasonography by a blinded assessor.

The primary endpoint is hemidiaphragmatic paralysis defined as ≥25% reduction in diaphragmatic excursion from baseline. Partial and complete paralysis will be analyzed as a composite binary outcome.

Interventions

  • Other Interscalene Nerve Block
    Procedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg)
  • Other shoulder pericapsular nerve group block
    Procedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg)

Primary outcome measures

  • Hemidiaphragmatic Paralysis (HDP) [Time frame: 30 minutes after block performance]
Secondary outcome measures (5)
  • Complete hemidiaphragmatic paralysis (≥75% reduction or paradoxical motion) [Time frame: 30 minutes after block performance]
  • Absolute and percentage change in diaphragmatic excursion [Time frame: 30 minutes after block performance]
  • Total 24-hour tramadol consumption (mg) [Time frame: postoperative 24 hours]
  • NRS pain scores (from 0 to 10: 0 stands for no pain, 10 stands for severe pain) [Time frame: postopertaive 2 hours, 6 hours, 12 hours, 24 hours]
  • Rescue morphine consumption (mg) [Time frame: postoperative 24 hours]

Eligibility criteria

Inclusion criteria

  • ASA physical status I-III
  • Scheduled for elective shoulder surgery under general anesthesia
  • Able to provide informed consent

Exclusion criteria

  • Pre-existing diaphragmatic dysfunction
  • Severe COPD or restrictive pulmonary disease
  • Neuromuscular disorders
  • BMI > 40 kg/m²
  • Coagulopathy
  • Infection at injection site
  • Allergy to local anesthetics
  • Inability to undergo diaphragmatic ultrasound assessment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07486349 · Shoulder Pericapsular Block

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗