Opioid-free Anesthesia and Thoracoscopy Surgery | NCT05308355

Studies
Opioid-free Anesthesia and Thoracoscopy Surgery

NCT05308355

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Opioid Free Anesthesia
Thoracic Surgery

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2022Actual

Primary Completion Date

Apr 30, 2023Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Feb 15, 2022

First Submission Date that Met QC Criteria

Mar 25, 2022

First Posted Date

Apr 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of a service OFA (Opioid-free Anesthesia) protocol on post-operative pain of patients operated on by video-thoracoscopic carcinologic surgery by counting them to a group of patients receiving standard general anesthesia with opioid.

Detailed Description

A service protocol based on opioid-free anesthesia in patients undergoing pulmonary carcinologic surgery under video-thoracoscopy will be evaluated.

The investigative team want to recruit 100 patients prospectively. These patients will be randomly assigned on the day of surgery between OFA (Opioid Free Anesthesia) and OBA (Opioid Based Anesthesia).

Anesthesia and analgesia of patients in the OFA group will be performed without morphine according to the validated local protocol. We will use level 1 and 2 analgesics (paracetamol, NSAIDs and nefopam) associated with an erector spine block and anesthesia under propofol, dexmedetomidine and ketamine ivse.

Patients in the OBA group will have so-called "basic" anesthesia and analgesia with opioids according to usual practice.

Postoperative pain by collecting morphine consumption in the first 48 hours postoperatively between the two groups will be compared.

Chronic neuropathic postoperative pain will also be collected by a telephone questionnaire at 3 months postoperative.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OFA : Opioid Free Anesthesia		Opioid-free surgery. Analgesia provided by attenuation analgesic 1, dexmedetomidine, ketamine and general anesthesia by propofol. Regional loco anesthesia is performed in the OFA group and possible in the OBA group. It's local service protocol used since 1 year.
OBA : Opioid Based Anesthesia		Conventional anesthesia with Propofol and Sufentanil boli with the possibility of regional loco anesthesia.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morphine consumption	Total morphine consumption over the first 48 post operative hours in milligrammes	Day 2

Secondary Outcomes

Measure	Description	Time Frame
Preoperatory haemodynamic tolerance	Maximum doses of norepinephrine intraoperatively in µg/kg/min.	Day 0
Quality of intraoperative anesthesia	Duration of surgery (time between entering the operating room and leaving the room) in minutes.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient
Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours

Exclusion Criteria:

Patient with unstable unstable unstable coronary artery disease,
Patient contraindicated for the use of dexmedetomidine: heart rate<50 / min, High degree atrioventricular block (2 and 3) unless fitted (carrier of a pacemaker),
Patient on beta-blocker, allergy to Dexdor®,
Patient allergic to other drugs used in OFA (Paracetamol and NSAIDs).
Renal insufficiency patient with creatinine clearance<30ml/min will not be excluded but will not receive NSAIDs.
Minor patient,
Adult patient under guardianship or curators.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing lung oncology surgery under video-thoracoscopy lasting more than 2 hours.

Patients will be randomly assigned to a group without a random draw. Only the anesthesiologist trained at the OFA will be able to do the OFA

Sampling Method

Probability Sample

Name	Affiliation	Role
Julien CADIET, PH	Nantes University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nantes		Nantes		44093	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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