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Opioid Free Versus Opioid Based Anaesthesia for Secondary Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study. (OFOBA)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring free flap reconstruction surgery, anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women aged 18 or older.
  2. Patients with a French health insurance coverage (having a French social security number).
  3. Patient eligible for secondary free flap reconstruction surgery of the breastunder general anaesthesia.
  4. Patient who has given written consent to participate in accordance with the regulations.
  5. Having a negative blood pregnancy test for patients of childbea ring age.

Exclusion Criteria:

  1. Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
  2. Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
  3. Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
  4. Treatment with ACEI/ARB.
  5. Severe asthma.
  6. Symptomatic gastric or duodenal ulcer with or without treatment.
  7. Baseline systolic blood pressure < 100 mmHg.
  8. Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
  9. Patient already included in another therapeutic trial evaluating an experimental molecule.
  10. Persons deprived of liberty or under guardianship.
  11. Patients with suspected difficulties in assessing pain on a scale.
  12. Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.

Sites / Locations

  • Institut Curie ParisRecruiting
  • Institut Curie Saint-CloudRecruiting
  • Gustave Roussy, Cancer Campus, Grand ParisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OFA group

CGA control group

Arm Description

OFA (Opioid Free Anaesthesia) group:

CGA (Conventional General Anaesthesia) control group:

Outcomes

Primary Outcome Measures

comparison of Morphine consumption in the two groups

Secondary Outcome Measures

Assessment of vasopressor requirement and total intraoperative filling volume
Assessment of the state of consciousness on arrival in the PACU
Assessment of the incidence of PONV in the PACU, at D0, D1 and D2
Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2
Dose of morphine given in titration in the PACU (mg)
Number of boluses demand on PCA during the first 48 hours postoperatively
DN4 score (Neuropathic Pain 4) on D2, D4, M1, M3 and M6
Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)
Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate
Pain management satisfaction scores (score from 0 to 10) at discharge
Collection of serious adverse events between D0 (date of surgery) and D30
Dose of intraoperative rescue remifentanil in the OFA group (mcg)

Full Information

First Posted
June 27, 2022
Last Updated
October 11, 2023
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT05439005
Brief Title
Opioid Free Versus Opioid Based Anaesthesia for Secondary Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Acronym
OFOBA
Official Title
Opioid Free Versus Opioid Based Anaesthesia for Secondary Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
March 15, 2026 (Anticipated)
Study Completion Date
March 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CGA control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
free flap reconstruction surgery, anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OFA group
Arm Type
Experimental
Arm Description
OFA (Opioid Free Anaesthesia) group:
Arm Title
CGA control group
Arm Type
No Intervention
Arm Description
CGA (Conventional General Anaesthesia) control group:
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine+Lidocaine
Primary Outcome Measure Information:
Title
comparison of Morphine consumption in the two groups
Time Frame
during the first 48 hours postoperatively
Secondary Outcome Measure Information:
Title
Assessment of vasopressor requirement and total intraoperative filling volume
Time Frame
end of surgery
Title
Assessment of the state of consciousness on arrival in the PACU
Time Frame
on arrival in the PACU
Title
Assessment of the incidence of PONV in the PACU, at D0, D1 and D2
Time Frame
in the PACU, at D0, D1 and D2
Title
Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2
Time Frame
in the PACU, at D0, D1 and D2
Title
Dose of morphine given in titration in the PACU (mg)
Time Frame
in the PACU
Title
Number of boluses demand on PCA during the first 48 hours postoperatively
Time Frame
the first 48 hours postoperatively
Title
DN4 score (Neuropathic Pain 4) on D2, D4, M1, M3 and M6
Time Frame
on D2, D4, M1, M3 and M6
Title
Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)
Time Frame
at discharge
Title
Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate
Time Frame
at discharge
Title
Pain management satisfaction scores (score from 0 to 10) at discharge
Time Frame
at discharge
Title
Collection of serious adverse events between D0 (date of surgery) and D30
Time Frame
between D0 (date of surgery) and D30
Title
Dose of intraoperative rescue remifentanil in the OFA group (mcg)
Time Frame
at discharge

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patient eligible for secondary free flap reconstruction surgery of the breastunder general anaesthesia.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women aged 18 or older. Patients with a French health insurance coverage (having a French social security number). Patient eligible for secondary free flap reconstruction surgery of the breastunder general anaesthesia. Patient who has given written consent to participate in accordance with the regulations. Having a negative blood pregnancy test for patients of childbea ring age. Exclusion Criteria: Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron). Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency. Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment. Treatment with ACEI/ARB. Severe asthma. Symptomatic gastric or duodenal ulcer with or without treatment. Baseline systolic blood pressure < 100 mmHg. Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively. Patient already included in another therapeutic trial evaluating an experimental molecule. Persons deprived of liberty or under guardianship. Patients with suspected difficulties in assessing pain on a scale. Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Claire COYNE, PhD
Phone
0033156245765
Email
anne-claire.coyne@curie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mary SAAD, MD
Phone
0033147112371
Email
mary.saad@curie.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary SAAD, MD
Organizational Affiliation
Institut Curie Saint-Cloud
Official's Role
Study Director
Facility Information:
Facility Name
Institut Curie Paris
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Muret, MD
Email
jane.muret@curie.fr
First Name & Middle Initial & Last Name & Degree
jane Muret, MD
Facility Name
Institut Curie Saint-Cloud
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline ALBI, MD
Email
aline.albi-feldzer@curie.fr
First Name & Middle Initial & Last Name & Degree
Aline ALBI, MD
Facility Name
Gustave Roussy, Cancer Campus, Grand Paris
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Migena DEMIRI, MD
Email
migena.demiri@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Migena DEMIRI, MD

12. IPD Sharing Statement

Learn more about this trial

Opioid Free Versus Opioid Based Anaesthesia for Secondary Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.

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