Shoulder Pericapsular Block Versus Interscalene Block in Arthroscopic Shoulder Surgery

NCT07486349 | Not Yet Recruiting

• 1 other identifier: Shoulder Pericapsular Block
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hemidiaphragmatic Paralysis

Keywords

hemidiaphragmatic paralysis; intescalen block; shoulder pericapsular nerve group

Outcome Measures

Primary Outcomes (1)

• Hemidiaphragmatic Paralysis (HDP)

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

  30 minutes after block performance

Secondary Outcomes (5)

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

  30 minutes after block performance

• Absolute and percentage change in diaphragmatic excursion

  30 minutes after block performance

• Total 24-hour tramadol consumption (mg)

  postoperative 24 hours

• NRS pain scores (from 0 to 10: 0 stands for no pain, 10 stands for severe pain)

  postopertaive 2 hours, 6 hours, 12 hours, 24 hours

• Rescue morphine consumption (mg)

  postoperative 24 hours

Study Arms (2)

Shoulder PENG Block

ACTIVE COMPARATOR

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

Other: shoulder pericapsular nerve group block

Interscalene Block (ISB)

ACTIVE COMPARATOR

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

Other: Interscalene Nerve Block

Interventions

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)

Interscalene Block (ISB)

shoulder pericapsular nerve group block OTHER

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

Shoulder PENG Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-02