Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05922449
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2023-06-01
Brief Title:
Using Thoracic Paravertebral Block for Perioperative Lung Preservation During VATS Pulmonary Surgery
Sponsor:
Beijing Tongren Hospital
Organization:
Beijing Tongren Hospital
Study Overview
Official Title:
Using Thoracic Paravertebral Block for Perioperative Lung Preservation During VATS Pulmonary Surgery A Dual Center Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-03
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:
Background Postoperative pulmonary complications PPCs may extend the length of stay of patients and even increase perioperative mortality after video-assisted thoracoscopic VATS pulmonary surgery Thoracic paravertebral block TPVB can provide effective analgesia after VATS however little is known about the effect of TPVB on PPCs This study aims to determine whether TPVB combined with general anesthesia results in reducing PPCs and achieve perioperative lung protection in VATS pulmonary surgery compared with simple general anesthesia
Methods A total of 302 patients undergoing VATS lobectomysegmentectomy will be randomly divided into two groups Paravertebral block group PV group and Control group C group Patients of PV group will receive thoracic paravertebral block 15 ml of 05 ropivacaine will be administered to the T4 and T7 thoracic paravertebral spaces respectively before general anesthesia Patients of C group will not undergo intervention Both groups of patients adopted protective ventilation strategy during operation Perioperative protective mechanical ventilation and standard fluid management will be applied in both groups Patient controlled intravenous analgesia was used for postoperative analgesia The primary endpoint is the composite outcome of PPCs within 7 days after surgery Secondary end points include blood gas analysis postoperative lung ultrasound score NRS score QoR-15 score hospitalization related indicators and long-term prognosis indicators
Methods A total of 302 patients undergoing VATS lobectomysegmentectomy will be randomly divided into two groups Paravertebral block group PV group and Control group C group Patients of PV group will receive thoracic paravertebral block 15 ml of 05 ropivacaine will be administered to the T4 and T7 thoracic paravertebral spaces respectively before general anesthesia Patients of C group will not undergo intervention Both groups of patients adopted protective ventilation strategy during operation Perioperative protective mechanical ventilation and standard fluid management will be applied in both groups Patient controlled intravenous analgesia was used for postoperative analgesia The primary endpoint is the composite outcome of PPCs within 7 days after surgery Secondary end points include blood gas analysis postoperative lung ultrasound score NRS score QoR-15 score hospitalization related indicators and long-term prognosis indicators
Detailed Description:
Surgical resection is still the go-to treatment for lung cancer which is the leading cause of cancer death As a minimally invasive operation video-assisted thoracoscopic surgery VATS has significantly reduced surgical trauma and systemic inflammation and has become the standard treatment method for lung cancer
Postoperative pulmonary complications PPCs are one of the most common complications after thoracoscopic lung cancer surgery with an incidence of 408 PPCs increase hospitalization time hospitalization cost and perioperative mortality and affect the treatment effect and utilization of medical resources One of the most pressing clinical issues is how to lower the prevalence of PPCs Previous research has shown that lung protective ventilation strategies including low tidal volume positive end expiratory pressure PEEP low inhalation oxygen concentration etc have a good prognosis in patients with lung injury but they may not fully prevent acute lung injury caused by one-lung ventilation OLV during VATS
The incidence of pain 24 hours after VATS was 38 and the incidence of chronic pain 6 months after VATS was 25 Poor postoperative analgesia will affect postoperative recovery which may raise the risk of pulmonary complications due to insufficient respiratory function and weak sputum excretion Thus it is crucial to effectively control acute discomfort following VATS
Ultrasound guided thoracic paravertebral block TPVB is a commonly used regional block technique in thoracic surgery Local anesthetics can be injected into the paravertebral space to block the ipsilateral sympathetic and somatosensory nerves TPVB combined with general anesthesia GA can reduce the pain after VATS decreases the expression of matrix metalloproteinase-9 reduce the inflammatory reaction after thoracic surgery improve the postoperative survival rate by blocking the unilateral sympathetic nerve improve the postoperative rehabilitation of patients after VATS lung cancer radical surgery and reduce the postoperative tumor recurrence According to a recent retrospective propensity matching analysis TPVB and GA together were linked to a decreased incidence of PPCs 298 vs 342 However a prospective study on the effects of GA combined with GA alone vs GA coupled with TPVB on PPCs following VATS pulmonary surgery has not been retrieved
The aim of this study is designed to explore whether general anesthesia combined with thoracic paravertebral block can reduce atelectasis lung inflammation and lung injury compared to general anesthesia during VATS pulmonary surgery thereby reducing the incidence of postoperative pulmonary complications achieving lung protection and improving long-term prognosis of patients
Postoperative pulmonary complications PPCs are one of the most common complications after thoracoscopic lung cancer surgery with an incidence of 408 PPCs increase hospitalization time hospitalization cost and perioperative mortality and affect the treatment effect and utilization of medical resources One of the most pressing clinical issues is how to lower the prevalence of PPCs Previous research has shown that lung protective ventilation strategies including low tidal volume positive end expiratory pressure PEEP low inhalation oxygen concentration etc have a good prognosis in patients with lung injury but they may not fully prevent acute lung injury caused by one-lung ventilation OLV during VATS
The incidence of pain 24 hours after VATS was 38 and the incidence of chronic pain 6 months after VATS was 25 Poor postoperative analgesia will affect postoperative recovery which may raise the risk of pulmonary complications due to insufficient respiratory function and weak sputum excretion Thus it is crucial to effectively control acute discomfort following VATS
Ultrasound guided thoracic paravertebral block TPVB is a commonly used regional block technique in thoracic surgery Local anesthetics can be injected into the paravertebral space to block the ipsilateral sympathetic and somatosensory nerves TPVB combined with general anesthesia GA can reduce the pain after VATS decreases the expression of matrix metalloproteinase-9 reduce the inflammatory reaction after thoracic surgery improve the postoperative survival rate by blocking the unilateral sympathetic nerve improve the postoperative rehabilitation of patients after VATS lung cancer radical surgery and reduce the postoperative tumor recurrence According to a recent retrospective propensity matching analysis TPVB and GA together were linked to a decreased incidence of PPCs 298 vs 342 However a prospective study on the effects of GA combined with GA alone vs GA coupled with TPVB on PPCs following VATS pulmonary surgery has not been retrieved
The aim of this study is designed to explore whether general anesthesia combined with thoracic paravertebral block can reduce atelectasis lung inflammation and lung injury compared to general anesthesia during VATS pulmonary surgery thereby reducing the incidence of postoperative pulmonary complications achieving lung protection and improving long-term prognosis of patients
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