OFA in Thoracic Surgery

Study Overview
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Brief Summary
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to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value

Detailed Description
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Opioids used to have its irreplaceable role in standard opioid-based anesthesia, yet with the help of hypnotics, local anesthetics, anti-inflammatory drugs, α-2 agonists and epidural techniques, opioid-free anesthesia (OFA) has been proved to be safe and feasible for non-cardiac major surgeries. Opioid-sparing anesthesia (OSA) is encouraged by the needs of enhanced recovery and recommended by the latest guidelines for anesthesia of lung surgery. According to previous studies, both opioid-sparing and opioid-free anesthesia would reduce the incidence of opioid-related adverse events and speed up the postoperative recovery to some extent, yet no studies ever are dedicated to compare these two different techniques.

Official Title
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The Efficacy and Safety of Opioid-free Anesthesia(OFA) for Non-small-cell Lung Cancer Resection and Its Underlying Clinical Value: a Prospective Study

Conditions
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Thoracic Cancer

Intervention / Treatment
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* Procedure: opioid free anesthesia
* Procedure: Opioid-sparing anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: going through thoracoscopic lung surgery including lobectomy, segmentectomy, single or multiple wedge resection, and two of the above procedures combined; able to complete the pain scoring face-to-face; no cognitive dysfunction or history of anesthetic drug allergy; ASA grade I-II Exclusion Criteria: -psychological disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: opioid free anesthesia<br>opioid free anesthesia | Procedure: opioid free anesthesia<br>* Instead of use of large amount of opioids for intraoperative stress response and postoperative pain controlling, during the whole perioperative period patients received no opioid at all. intravenous local anesthetics and thoracic epidural were used.<br>|
| Placebo Comparator: Opioid-sparing anesthesia<br>Opioid-sparing anesthesia | Procedure: Opioid-sparing anesthesia<br>* patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute postoperative pain scores | visual analog scale was used | day1 postoperation | 
| acute postoperative pain scores | visual analog scale was used | day2 postoperation | 
| occurrence of postoperative opioid-related adverse events | occurrence of postoperative opioid-related adverse events | day1 postoperation | 
| occurrence of postoperative opioid-related adverse events | occurrence of postoperative opioid-related adverse events | day2 postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse free survival and overall survival | relapse free survival and overall survival | within 5 years | 
| occurrence of episodes of postoperative pain (VAS ≥4) | occurrence of episodes of postoperative pain (VAS ≥4) | within 48hours | 
| PCEA bolus consumption | PCEA bolus consumption | within 48hours | 
| need for rescue intravenous opioids or any type of painkiller | need for rescue intravenous opioids or any type of painkiller | within 48hours | 
| hospital length of stay and total hospital expenses | hospital length of stay and total hospital expenses | within 10days | 
| Pathologic results and TNM rating | Pathologic results and TNM rating | within one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid free anesthesia, non small cell lung caner