Video-Assisted Thoracoscopic Surgery Clinical Trial
Official title:
Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries
Verified date | September 2022 |
Source | University at Buffalo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intercostal nerve block, performed under the guidance of videoscope, is a part of standard anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this double-blind, prospective, multi-center, randomized, controlled clinical trial the investigators aim to compare preemptive versus post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy pain.
Status | Completed |
Enrollment | 36 |
Est. completion date | March 30, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: Patients will be eligible to enroll in this study if they: - Have physical status within ASA class II or III - Are between 18 and 85 years of age - Are candidates for VATS - Are able to complete VAS assessments - Are competent to sign the informed consent form Exclusion Criteria: Patients will not be enrolled in this study if they: - Are pregnant - Have allergy to ropivacaine or hydromorphone - Have renal insufficiency (eGFR<60mL/min/1.73m2) - Have hepatic insufficiency (AST, ALT, or both >60 U/L) or cirrhosis - Have a predicted postoperative forced vital capacity (FVC) of <40%, predicted forced expiratory volume at 1s (FEV1) <40% - Have coagulopathy (platelet count<50000, INR>2, or both) - Have a history of opioid addiction, chronically taking opioids, currently taking high dose of opioids or currently taking opioid agonist+antagonist (e.g. Suboxone®) - Are taking nonsteroidal anti-inflammatory drug, including aspirin, within a week prior to surgery (since the analgesic effects of NSAID drugs may become confounding factors). |
Country | Name | City | State |
---|---|---|---|
United States | VA Western New York Healthcare System | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
University at Buffalo | The VA Western New York Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score | VAS scores at rest will be recorded right after surgery and compared in both groups | 0 | |
Primary | Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score | VAS scores at rest will be recorded 6 hours after surgery and compared in both groups | 6 hours | |
Primary | Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score | VAS scores at rest will be recorded 12 hours after surgery and compared in both groups | 12 hours | |
Primary | Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score | VAS scores at rest will be recorded 18 hours after surgery and compared in both groups | 18 hours | |
Primary | Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score | VAS scores at rest will be recorded 24 hours after surgery and compared in both groups | 24 hours | |
Primary | Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score | VAS scores at rest will be recorded 48 hours after surgery and compared in both groups | 48 hours | |
Primary | Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score | VAS scores at rest will be recorded 72 hours after surgery and compared in both groups | 72 hours | |
Secondary | Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC) | Postoperative delirium profiles will be measured 12 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC) | 12 hours | |
Secondary | Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC) | Postoperative delirium profiles will be measured 24 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC) | 24 hours | |
Secondary | Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC) | Postoperative delirium profiles will be measured 36 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC) | 36 hours | |
Secondary | Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC) | Postoperative delirium profiles will be measured 48 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC) | 48 hours | |
Secondary | PaO2/FIO2 ratio right after surgery | PaO2 (mmHg kPa) and FIO2 (percent) will be recorded from atrial blood gas examination and the ratio will be calculated | 0 hours | |
Secondary | Total hospital length of stay | The investigators will assess length of stay by evaluating medical records and calculate length of stay in days, using date of discharge and date of admission | up to 2 weeks | |
Secondary | Need for non-invasive positive pressure ventilation (NIPPV) | The investigators will assess the need for NIPPV by evaluating medical records to asses if patients received NIPPV with the discretion of the managing physician during their hospitalization | up to two weeks | |
Secondary | Need for mechanical ventilation | The investigators will assess the need for mechanical ventilation by evaluating medical records to asses if patients received mechanical ventilation with the discretion of the managing physician during their hospitalization | up to two weeks |
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