Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356038
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-22
Brief Title:
Phrenic Nerve Infiltration Pulmonary Expansion and Pain Control
Sponsor:
Azienda Ospedaliera SantAndrea
Organization:
Azienda Ospedaliera SantAndrea
Study Overview
Official Title:
Phrenic Nerve Infiltration a Good Practice to Combine Pulmonary Expansion and Pain Control in Patients With High-risk of Prolonged Air Leak
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 randomization into group A 22 patients received intra-operative phrenic nerve infiltration with Ropivacaine 10 mgml 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 comparedThe 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
Detailed Description:
This prospective randomized trial received approbation by the institutional review board Prot n 76 SA2022 RIF CE 66822022 and was conducted in accordance with the Declaration of Helsinki Written informed consent was obtained from all patients
Patients were defined at risk for PAL in accordance with 2019 Society of Thoracic Surgery score-criteria of PAL This is an aggregate score specifically designed for lung resection assigning an odd risk to each patient based on the most common predictors for prolonged air leak including Body Mass Index _255 kgm2 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
All patients received pre-operative physical examination routine blood tests pulmonary functional test spirometry and arterial blood gas analysis and cardiac tests according to the personal clinical history Imaging collection includes Total Body Computed Tomography CT and Positron Emission Tomography PET Central tumours required bronchoscopy to assess an eventual endobronchial invasion and to obtain histological diagnosis If N1N2 staging was clinically suspected patients underwent Endo-Bronchial Ultra-Sonography EBUS with eventual Trans-Bronchial Needle Aspiration TBNA or mediastinoscopy
Exclusion criteria for the study were wedge resections pneumonectomy neoplasms infiltrating diaphragm andor chest wall patients with congenital or acquired neurological diseases chronic pain osteo-muscular pathologies affecting the shoulder
All candidate patients for surgery underwent lung resection with a muscle sparing thoracotomy lateral 5-6 cm incision on the fifth intercostal space to reduce bias due by different surgical approaches on the post-operative pain
In group A patients received the intra-operative infiltration of phrenic nerve by the surgeon who injected 10 ml of Ropivacaine 075 the same procedure routinely adopted in our clinical practice of local analgesia at the level of intercostal spaces in the peri-neurotic pericardial fat near the diaphragm Infiltration is made with a deflated lung after pulmonary resection and chest tube insertion
Chest tubes were connected to a pleur-evac device with a system to register air leaks DrentechTM Palm Evo Redax
All patients received Chest X-Rays in post-operative day 1 3 5 Pain control was assessed using Numeric Rating Scale NRS from 0 no pain to 10 maximum level of pain at 24-hors and 72-hours from surgery Even the need for additional antalgic medicaments was registered All patients started pulmonary rehabilitation programs mobilization and respiratory exercises on post-operative day 1
Data were collected and stored in an Excel database Microsoft Corp Redmond Wash and were analyzed using statistical package SPSS version 250 SPSS Software IBM Corp Armonk NY USA Data collected were then analyzed and compared between the two groups Values were expressed as mean standard deviation SD for continuous variables and as absolute number and percentage in categorical variables Comparison of categorical variables was performed by c2 test using Fischer exact test Comparison of qualitative variables was performed by student t-test Significance was defined as a P value of less than 005 The adjusted odd ratios ORs and 95 confidence intervals CI were calculated to estimate and measure the association using 1000 bootstrapping samples
Patients were defined at risk for PAL in accordance with 2019 Society of Thoracic Surgery score-criteria of PAL This is an aggregate score specifically designed for lung resection assigning an odd risk to each patient based on the most common predictors for prolonged air leak including Body Mass Index _255 kgm2 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
All patients received pre-operative physical examination routine blood tests pulmonary functional test spirometry and arterial blood gas analysis and cardiac tests according to the personal clinical history Imaging collection includes Total Body Computed Tomography CT and Positron Emission Tomography PET Central tumours required bronchoscopy to assess an eventual endobronchial invasion and to obtain histological diagnosis If N1N2 staging was clinically suspected patients underwent Endo-Bronchial Ultra-Sonography EBUS with eventual Trans-Bronchial Needle Aspiration TBNA or mediastinoscopy
Exclusion criteria for the study were wedge resections pneumonectomy neoplasms infiltrating diaphragm andor chest wall patients with congenital or acquired neurological diseases chronic pain osteo-muscular pathologies affecting the shoulder
All candidate patients for surgery underwent lung resection with a muscle sparing thoracotomy lateral 5-6 cm incision on the fifth intercostal space to reduce bias due by different surgical approaches on the post-operative pain
In group A patients received the intra-operative infiltration of phrenic nerve by the surgeon who injected 10 ml of Ropivacaine 075 the same procedure routinely adopted in our clinical practice of local analgesia at the level of intercostal spaces in the peri-neurotic pericardial fat near the diaphragm Infiltration is made with a deflated lung after pulmonary resection and chest tube insertion
Chest tubes were connected to a pleur-evac device with a system to register air leaks DrentechTM Palm Evo Redax
All patients received Chest X-Rays in post-operative day 1 3 5 Pain control was assessed using Numeric Rating Scale NRS from 0 no pain to 10 maximum level of pain at 24-hors and 72-hours from surgery Even the need for additional antalgic medicaments was registered All patients started pulmonary rehabilitation programs mobilization and respiratory exercises on post-operative day 1
Data were collected and stored in an Excel database Microsoft Corp Redmond Wash and were analyzed using statistical package SPSS version 250 SPSS Software IBM Corp Armonk NY USA Data collected were then analyzed and compared between the two groups Values were expressed as mean standard deviation SD for continuous variables and as absolute number and percentage in categorical variables Comparison of categorical variables was performed by c2 test using Fischer exact test Comparison of qualitative variables was performed by student t-test Significance was defined as a P value of less than 005 The adjusted odd ratios ORs and 95 confidence intervals CI were calculated to estimate and measure the association using 1000 bootstrapping samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None