OFA in Thoracic Surgery

Shanghai Zhongshan Hospital60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Thoracic Cancer

Interventions

opioid free anesthesiaPROCEDURE

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.

Opioid-sparing anesthesiaPROCEDURE

patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

180 Fenglin Road

Shanghai, China

RECRUITING

Zhongshan Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

acute postoperative pain scores

visual analog scale was used

Time frame: day1 postoperation

acute postoperative pain scores

visual analog scale was used

Time frame: day2 postoperation

occurrence of postoperative opioid-related adverse events

Time frame: day1 postoperation

occurrence of postoperative opioid-related adverse events

Time frame: day2 postoperation

Secondary Outcomes

relapse free survival and overall survival

Time frame: within 5 years

occurrence of episodes of postoperative pain (VAS ≥4)

Time frame: within 48hours

PCEA bolus consumption

Time frame: within 48hours

need for rescue intravenous opioids or any type of painkiller

Time frame: within 48hours

hospital length of stay and total hospital expenses

Central Contacts

SHUWEI WANG

CONTACT

+8613564440601 veronicawang228@126.com

Data from ClinicalTrials.gov

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