Opioid-free Anesthesia in Thoracic Surgery

Completed

• Conditions: Thoracic; Surgery
• Interventions: Other: Post-operative care

• Registration Number: NCT04246099
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

No study has been conducted to demonstrate the feasibility and safety of an Opioid-Free Anesthesia (OFA) protocol compared to Opioid-Based Anesthesia (OBA) in thoracic surgery, at risk for intense post-operative pain, to improve patient care. The aim of the present study was to evaluate the effect of OFA on post-operative opioids consumption, pain and the post-operative period after lobectomy by Video-Assisted Thoracoscopy Surgery (VATS). systems.

Investigators perform a retrospective, single-center study in 2019. Patients were divided into two groups: OFA (with dexmedetomidine) or OBA (sufentanyl).

Investigators analyse the total postoperative opioid consumption in the 48 h after surgery. Investigators asses pain intensity in the 48 h after surgery, operative hemodynamic stability, Post-Operative Pain (POP) in Post-Anesthesia Care Unit (PACU) and POP on day 30.

All data are available in the medical record

Hypothesis: OFA can reduce post-operative opioids consumption, pain in lobectomy by video-assisted thoracoscopy surgery (VATS).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-11-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy
• Opioid Free Anesthesia (OFA) administration was left to the discretion of the attending anesthetist according to his or her practices and habits.
• age 18 or over
• lobectomy or wedge resection by Video-Assisted Thoracoscopy Surgery (VATS)

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Exclusion Criteria

• toxicomania,
• epidural analgesia use,
• thoracotomy conversion
• Patient-Controlled Analgesia with morphine (PCA)
• Patient who object to take part of the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group opioid free anesthesia	Post-operative care	Patient benefit of the opioid free anesthesia protocol
Group opioid based anesthesia	Post-operative care	Patient don't benefit of the opioid free anesthesia protocol

Primary Outcome Measures

Name	Time	Method
Cumulative dose of postoperative opioid	48 hours	The primary endpoint was the cumulative dose of postoperative opioid in the first 48 h (D2) (in milligrams of oral morphine equivalent) which included morphine and tramadol after conversion (1mg of intra-veinous morphine = 3 mg of oral morphine, and 10 mg of oral morphine = 50 mg of oral tramadol)

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care - Louis Pradel University Hospital - Hospices Civils, Lyon, France; 🇫🇷 Bron, France