Opioid-free Anesthesia in Thoracic Surgery

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).

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Key information

Conditions

Thoracic Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bron, 69500, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Post-operative care

Other

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.

Primary outcomes

Cumulative dose of postoperative opioid

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: VATOFA

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jan 29, 2020
Registry last updated: Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed