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NCT Number: NCT07486349

Shoulder Pericapsular Block Versus Interscalene Block in Arthroscopic Shoulder Surgery

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interscalene Nerve Block

Other

Procedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg)

shoulder pericapsular nerve group block

Other

Procedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg)

Primary outcomes

  1. Hemidiaphragmatic Paralysis (HDP)

    Time frame: 30 minutes after block performance

    ≥25% reduction in diaphragmatic excursion from baseline measured by ultrasound M-mode.

Secondary outcomes

  1. Complete hemidiaphragmatic paralysis (≥75% reduction or paradoxical motion)

    Time frame: 30 minutes after block performance

    ≥75% reduction or paradoxical motion

  2. Absolute and percentage change in diaphragmatic excursion

    Time frame: 30 minutes after block performance

    change in diaphragmatic excursion

  3. Total 24-hour tramadol consumption (mg)

    Time frame: postoperative 24 hours

    Total 24-hour tramadol consumption (mg)

  4. 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

    Postoperative pain scores

  5. Rescue morphine consumption (mg)

    Time frame: postoperative 24 hours

    Rescue morphine consumption (mg)

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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