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ACTIVE NOT RECRUITING
NCT06356038
NA

Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control

Sponsor: Azienda Ospedaliera "Sant'Andrea"

View on ClinicalTrials.gov

Summary

Between January 2021-2023, 65 consecutive patients at risk for PAL (defined in accordance to "2019 Society of Thoracic Surgery score-criteria of PAL") underwent lung resection (lobectomy or sublobar resection) for malignancy. 5 patients were lost. The remaining have been assigned with a 1:2 randomization into: group A (22 patients), received intra-operative phrenic nerve infiltration with Ropivacaine 10 mg/ml in the peri-neurotic fat on the pericardium and group B (38 patients), did not receive infiltration. Data on hemidiaphragm elevation, air leaks, pain at 24 and 72 hours post-surgery, shoulder pain, length of hospital stay, length of chest tube permanence, were retrospectively collected and compared.The aim of the study is to investigate the effect of intra-operative phrenic nerve infiltration with long acting anesthetic in patients at high risk for PAL, improving pulmonary expansion after surgery, and reducing air leaks, while controlling post-operative pain.

Official title: Phrenic Nerve Infiltration: a Good Practice to Combine Pulmonary Expansion and Pain Control in Patients With High-risk of Prolonged Air Leak

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2022-03-09

Completion Date

2025-01-02

Last Updated

2024-04-10

Healthy Volunteers

No

Interventions

PROCEDURE

intra-operative phrenic nerve infiltration

patients received the intra-operative infiltration of phrenic nerve by the surgeon who injected 10 ml of Ropivacaine 0.75% (the same procedure routinely adopted in our clinical practice for local analgesia at the level of the intercostal space) in the peri-neurotic pericardial fat, near the diaphragm. Infiltration is made with a deflated lung, after pulmonary resection and chest tube insertion.

Locations (1)

Azienda Ospedaliera "Sant'Andrea"

Roma, Italy