Postoperative Complications Clinical Trial
Official title:
Impact of the Administration of Intravenous or Paravertebral Lidocaine in Continuous Perfusion During the Intraoperative Period of Lung Resection Surgery on the Appearance of Postoperative Complications
Verified date | August 2021 |
Source | Hospital General Universitario Gregorio Marañon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to analyze the impact of the intravenous (IV) or paravertebral (PV) lidocaine administration during the intraoperative period of lung resection surgery on the appearance of postoperative complications. We design a randomized, controlled and blinded study to be performed in 153 patients with 3 arms: 1) Lidocaine IV + PV saline 2) saline IV + PV lidocaine, 3) remifentanil IV + PV saline. Perioperative analysis of inflammatory biomarkers in bronchoalveolar lavage and serum. Follow-up of the postoperative course, especially the appearance of postoperative complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical results.
Status | Completed |
Enrollment | 156 |
Est. completion date | July 2, 2021 |
Est. primary completion date | June 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients of both sexes undergoing lung resection surgery at the Thoracic Surgery Service at the Gregorio Maranón hospital. - Patients who voluntarily accept to participate in the study and sign the informed consent - Age> 18 years and legally capable - Scheduled surgery. - Functional respiratory tests with forced expiratory volume at one second > 50% or forced vital capacity > 50% preoperatively performed on these patients routinely. - Not having been on chronic treatment with oral corticosteroids or immunosuppressants three months before surgery. - Patients without previous history of liver disease. Exclusion Criteria: - Pregnancy and lactation - Known hypersensitivity to amide-type local anesthetics. - Transfusion of blood products in the previous 10 days. - Impossibility of performing mechanical ventilation for pulmonary protection. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Gregorio Maranon | Madrid |
Lead Sponsor | Collaborator |
---|---|
Francisco Andres de la Gala | Instituto de Salud Carlos III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative complications | to compare the proportion of patients included in the different scales of the Clavien-Dindo classification of postoperative complications reviewed for thoracic surgery in the three groups of patients. Patients will be followed from the day of hospital admission until hospital discharge and up to 30 days after the surgery | up to 30 days after intervention | |
Secondary | gas exchange | Compare the gas exchange (PaO2 / FiO2) at 24 hours after the intervention between the three groups of the study. | 24 hours | |
Secondary | Differences between three groups in Inflammatory biomarkers (IL 1, IL 2, IL 6, IL 8, IL 10, TNF alpha, MCP-1) measure in serum and bronchoalveolar lavage during 24 hours after the surgery. | To evaluate the effect of intravenous lidocaine on the inflammatory response in lung resection surgery by measuring the inflammatory biomarkers (Interleukin(IL) 1, IL 2, IL 6, IL8, IL 10, tumor necrosis factor alfa and monocyte chemoattractant protein) in serum and in bronchoalveolar lavage, compared to the other two groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively. Bronchoalveolar lavage is done just before the beginning of one lung ventilation and at the end of one lung ventilation | up to 24 hours of intervention | |
Secondary | Analgesic requirements of opioids in the first 24 hours after the surgery | To compare the analgesic requirements of opioids in the immediate postoperative period (first 24 hours after the surgery) between the three groups of the study. When patients will be admitted in the postoperative care Unit a patient controlled analgesia pump of intravenous morphine 0,1% (bolus of 1mg) will be connected. The total dose of morphine self-administered by the patient in the first 24 hours after surgery will be recorded. | 24 hours | |
Secondary | Special Care Units stay | To compare the average stay (measure in hours) in Special Care Units among the three groups of the study | up to 30 days after intervention | |
Secondary | Hospital stay | To compare the average hospital stay (measure in days) among the three groups of the study | up to 30 days after intervention | |
Secondary | Re-admissions in Special Care Units | To compare the number of re-admissions in Special Care Units among the three groups of the study in the 30 days after the intervention. | up to 30 days after intervention | |
Secondary | Postoperative cognitive dysfunction measure by mini mental state examination | To analyze the incidence of postoperative cognitive dysfunction (POCD) in the three groups by comparing the mini mental state examination performed at admission and 3 days after the intervention. | up to 3 days after intervention | |
Secondary | Neuro-inflammatory response measure by the synthesis of protein S-100 beta in serum | To evaluated the neuro-inflammatory response by the synthesis of protein S-100 beta measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively | up to 24 hours after intervention | |
Secondary | Neuro-inflammatory response measure by the synthesis of neuronal specific enolase in serum | To evaluated the neuro-inflammatory response by the synthesis of neuronal specific enolase measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively | up to 24 hours after intervention | |
Secondary | Neuro-inflammatory response measure by the synthesis of glial fibrillary acidic protein | To evaluated the neuro-inflammatory response by the synthesis of glial fibrillary acidic protein measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively | up to 24 hours after intervention |
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