Opioid-free Anesthesia in Thoracic Surgery (VATOFA)

Effect of Opioid-free Anesthesia on Perioperative Period After Video-assisted Thoracoscopic Lobectomy: a Retrospective Study

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).

Study Overview

• Status: Completed
• Conditions: Surgery; Thoracic
• Intervention / Treatment: Other: Post-operative care

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Department of Anesthesiology and Intensive Care - Louis Pradel University Hospital - Hospices Civils, Lyon, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy in Department of Anesthesiology and Intensive Care at Louis Pradel University Hospital.

If patient benefit of the OFA protocol, he was part of the group OFA (opioid free anesthesia) If patient don't benefit of the OFA protocol, he was part of the group OBA (opioid based anesthesia)

Description

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group opioid free anesthesia; Patient benefit of the opioid free anesthesia protocol	Other: Post-operative care; Retrospective collection of clinical data recorded in the electronic medical record. The following variables were continuously recorded in the institutional database: age, gender, body weight, height, personal medical history, American Society of Anesthesiologists (ASA) score, type of thoracic surgery, the duration of surgery, duration of anesthesia (from intubation to extubation), the duration of PACU stay, the need for morphine titration, epinephrine, norepinephrine. For data at day 30, the vast majority of patients were included in the enhanced recovery program and as such benefited from a consultation at 1 month with a coordination nurse who collected data on post-operative pain in a standardized manner. All data was extracted from investigators institutional database and collected by a physician who was not involved in the care of the study patients.
Group opioid based anesthesia; Patient don't benefit of the opioid free anesthesia protocol	Other: Post-operative care; Retrospective collection of clinical data recorded in the electronic medical record. The following variables were continuously recorded in the institutional database: age, gender, body weight, height, personal medical history, American Society of Anesthesiologists (ASA) score, type of thoracic surgery, the duration of surgery, duration of anesthesia (from intubation to extubation), the duration of PACU stay, the need for morphine titration, epinephrine, norepinephrine. For data at day 30, the vast majority of patients were included in the enhanced recovery program and as such benefited from a consultation at 1 month with a coordination nurse who collected data on post-operative pain in a standardized manner. All data was extracted from investigators institutional database and collected by a physician who was not involved in the care of the study patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative dose of postoperative opioid	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)	48 hours

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Post-operative pain
• Other Study ID Numbers: VATOFA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No