Clinical trial NCT05439005: Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Official title: Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: free flap reconstruction surgery
anaesthesia
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.


Eligibility criteria: 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 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.

Primary outcomes:
measure: comparison of Morphine consumption in the two groups
timeFrame: during the first 48 hours postoperatively
Secondary outcomes:
measure: Assessment of vasopressor requirement and total intraoperative filling volume
timeFrame: end of surgery
measure: Assessment of the state of consciousness on arrival in the PACU
timeFrame: on arrival in the PACU
measure: Assessment of the incidence of PONV in the PACU, at D0, D1 and D2
timeFrame: in the PACU, at D0, D1 and D2
measure: Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2
timeFrame: in the PACU, at D0, D1 and D2
measure: Dose of morphine given in titration in the PACU (mg)
timeFrame: in the PACU
measure: Number of boluses demand on PCA during the first 48 hours postoperatively
timeFrame: the first 48 hours postoperatively
measure: DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6
timeFrame: on D2, D4, M1, M3 and M6
measure: Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)
timeFrame: at discharge
measure: Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate
timeFrame: at discharge
measure: Pain management satisfaction scores (score from 0 to 10) at discharge
timeFrame: at discharge
measure: Collection of serious adverse events between D0 (date of surgery) and D30
timeFrame: between D0 (date of surgery) and D30
measure: Dose of intraoperative rescue remifentanil in the OFA group (mcg)
timeFrame: at discharge
measure: Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary);
timeFrame: the first 48 hours postoperatively
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie Paris
city: Saint-Cloud
country: France
facility: Institut Curie Saint-Cloud
city: Villejuif
country: France
facility: Gustave Roussy, Cancer Campus, Grand Paris
Study officials:
affiliation: Institut Curie Saint-Cloud
name: Mary SAAD, MD
role: STUDY_DIRECTOR
References: