Trials / Not Yet Recruiting
Not Yet RecruitingNCT07486349
Shoulder Pericapsular Block Versus Interscalene Block in Arthroscopic Shoulder Surgery
Ultrasound-Guided Interscalene Block Versus Shoulder Pericapsular Nerve Group (PENG) Block for Hemidiaphragmatic Paralysis in Elective Shoulder Surgery: A Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Marmara University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2026-10-01
- Completion
- 2026-12-01
- First posted
- 2026-03-20
- Last updated
- 2026-03-20
Source: ClinicalTrials.gov record NCT07486349. Inclusion in this directory is not an endorsement.