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

Breast Cancer Clinical Trial

— OFOBA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439005
• Other study ID #: IC 2021-07
• Status: Recruiting
• Phase: Phase 3
• Start date: December 7, 2022
• Est. completion date: March 15, 2026

Study information

• Verified date: April 2024
• Source: Institut Curie
• Contact: Anne-Claire COYNE, PhD
• Phone: 0033156245765
• Email: anne-claire.coyne[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine+Lidocaine

Locations

Country	Name	City	State
France	Institut Curie Paris	Paris
France	Institut Curie Saint-Cloud	Saint-Cloud
France	Gustave Roussy, Cancer Campus, Grand Paris	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of Morphine consumption in the two groups		during the first 48 hours postoperatively
Secondary	Assessment of vasopressor requirement and total intraoperative filling volume		end of surgery
Secondary	Assessment of the state of consciousness on arrival in the PACU		on arrival in the PACU
Secondary	Assessment of the incidence of PONV in the PACU, at D0, D1 and D2		in the PACU, at D0, D1 and D2
Secondary	Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2		in the PACU, at D0, D1 and D2
Secondary	Dose of morphine given in titration in the PACU (mg)		in the PACU
Secondary	Number of boluses demand on PCA during the first 48 hours postoperatively		the first 48 hours postoperatively
Secondary	DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6		on D2, D4, M1, M3 and M6
Secondary	Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)		at discharge
Secondary	Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate		at discharge
Secondary	Pain management satisfaction scores (score from 0 to 10) at discharge		at discharge
Secondary	Collection of serious adverse events between D0 (date of surgery) and D30		between D0 (date of surgery) and D30
Secondary	Dose of intraoperative rescue remifentanil in the OFA group (mcg)		at discharge
Secondary	Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary);		the first 48 hours postoperatively