Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control

NCT06356038 | Active Not Recruiting

• 1 other identifier: Prot. n. 76 SA/2022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prolonged air leak; phrenic nerve; local anaesthetic

Outcome Measures

Primary Outcomes (1)

• rate of pulmonary expansion due by phrenic nerve intra-operative local anaesthetic infiltration

  Rate of pulmonary re-expansion that was defined complete or near complete if lung achieved the 90% of lung surface to the XR; incomplete if lung surface was inferior to 90%. The rate of lung surface is calculated evaluating the "mean interpleural distance": the measurement corresponds to the average of the distances between lung and chest wall calculated at three points (apex, costophrenic sinus, midpoint) in a chest XR; from the average of the three measurements, the rate of lung collapse and the rate of expansion are estimated.

  two years

Secondary Outcomes (1)

• rate of post-operative pain control after intra-operative phrenic nerve infiltration with local anaesthetic

  two years

Study Arms (2)

Group A (phrenic nerve infiltration)

EXPERIMENTAL

Patients received intra-operative phrenic nerve infiltration with local anesthetic

Procedure: intra-operative phrenic nerve infiltration

Group B (no phrenic nerve infiltration)

NO INTERVENTION

Patients did not receive intra-operative infiltration

Interventions

intra-operative phrenic nerve infiltration PROCEDURE

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.

Group A (phrenic nerve infiltration)

Eligibility Criteria

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

You may qualify if:

• patients affected by lung cancer eligible for surgery
• patients with high risk for post-operative prolonged air leaks: Body Mass Index \<\_25.5 kg/m2 (7 points); lobectomy or bilobectomy (6 points); forced expiratory volume in 1 second (FEV1) \</= 70% (5 points); male sex (4 points); right upper lobe (3 points). A total score \> 17 is considered high risk for PAL

You may not qualify if:

• metastatic desease
• patients not eligible for surgery because low performance status
• pneumonectomy/ wedge resections
• tumors infiltrating phrenic nerve/ diaphragm
• patients with neurological disorders causing chronic pain

Sponsors & Collaborators

• Azienda Ospedaliera "Sant'Andrea": lead

Study Sites (1)

Azienda Ospedaliera "Sant'Andrea"

Roma, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 10, 2024
• Study Start: March 9, 2022
• Primary Completion: January 2, 2025
• Study Completion: January 2, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)