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Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control

NCT06356038 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

  • Prolonged Air Leak
  • Post-operative Pain

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.

Sponsors & Collaborators

  • Azienda Ospedaliera "Sant'Andrea"

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2025-01-02
Completion
2025-01-02

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06356038 on ClinicalTrials.gov