Opioid-free Anesthesia in Thoracic Surgery

NCT04246099 | Completed

• 1 other identifier: VATOFA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Thoracic; Surgery

Keywords

Post-operative pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group opioid free anesthesia

Patient benefit of the opioid free anesthesia protocol

Other: Post-operative care

Group opioid based anesthesia

Patient don't benefit of the opioid free anesthesia protocol

Other: Post-operative care

Interventions

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.

Group opioid based anesthesia; Group opioid free anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)