Opioid-Free versus Opioid-Based Anaesthesia for secondary free-flap reconstruction surgery of the breast: A phase III multicentric randomized controlled study

Opioid-Free versus Opioid-Based Anaesthesia for secondary free-flap reconstruction surgery of the breast: A phase III multicentric randomized controlled study - OFOBA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001139-98-FR

Enrollment

158

Registered

2022-04-25

Start date

2022-06-13

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia during secondary free flap reconstruction surgery of the breast. MedDRA version: 21.1 Level: LLT Classification code 10002323 Term: Anesthesia general System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10006305 Term: Breast reconstruction System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: DEXMEDETOMIDINE EVER PHARMA 100 microgrammes/mL Product Name: DEXMEDETOMIDINE Pharmaceutical Form: Solution for infusion INN or Proposed INN: DEXMEDETOMIDINE HYDROCHLORIDE CAS Number: 1451

Eligibility

Sex/Gender

All

Inclusion 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 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 childbearing age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 158 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 158

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CGA control group;Secondary Objective: 1. Compare intraoperative hemodynamic stability. 2. Compare sedation scores in the Post-Anaesthesia Care Unit. 3. Compare the incidence of postoperative nausea and vomiting in the PACU, at D0, D1 and D2. 4. Compare the self-evaluation of pain at rest and during mobilization on the Visual Analogical Evaluation scale in the PACU, at D0, D1 and D2. 5. Compare morphine consumption in titration in the PACU. 6. Compare number of boluses demand on PCA in the two groups. 7. Compare the DN4 pain scores at D2, D4, 1 month, 3 months and 6 months post-operatively. 8. Compare the PACU length of stay and the in-hospital postoperative length of stay. 9. Compare the flap failure rate and the re-exploration of the microsurgical anastomosis rate. 10. Compare the patients' pain management satisfaction scores at discharge. 11. Evaluate the incidence of serious adverse events during 30 days after the surgery. 12. Evaluate rescue remifentanil consumption in the OFA group. ;Primary end point(s): Morphine consumption during the first 48 hours postoperatively (mg).;Timepoint(s) of evaluation of this end point: During the first 48 hours postoperatively	—

Measure

Time frame

Main Objective: Compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CGA control group;Secondary Objective: 1. Compare intraoperative hemodynamic stability. 2. Compare sedation scores in the Post-Anaesthesia Care Unit. 3. Compare the incidence of postoperative nausea and vomiting in the PACU, at D0, D1 and D2. 4. Compare the self-evaluation of pain at rest and during mobilization on the Visual Analogical Evaluation scale in the PACU, at D0, D1 and D2. 5. Compare morphine consumption in titration in the PACU. 6. Compare number of boluses demand on PCA in the two groups. 7. Compare the DN4 pain scores at D2, D4, 1 month, 3 months and 6 months post-operatively. 8. Compare the PACU length of stay and the in-hospital postoperative length of stay. 9. Compare the flap failure rate and the re-exploration of the microsurgical anastomosis rate. 10. Compare the patients' pain management satisfaction scores at discharge. 11. Evaluate the incidence of serious adverse events during 30 days after the surgery. 12. Evaluate rescue remifentanil consumption in the OFA group. ;Primary end point(s): Morphine consumption during the first 48 hours postoperatively (mg).;Timepoint(s) of evaluation of this end point: During the first 48 hours postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): 1. Assessment of vasopressor requirement and total intraoperative filling volume. 2.Assessment of the state of consciousness on arrival in the PACU (S0 Awake, S1 Drowsy, responds to call, S2 Drowsy responds to touch, S3 non awake comatose). 3.Assessment of the incidence of PONV in the PACU, at D0, D1 and D2. 4.Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2. 5.Dose of morphine given in titration in the PACU (mg). 6.Number of boluses demand on PCA during the first 48 hours postoperatively. 7.DN4 score (Neuropathic Pain 4) on D2, D4, M1, M3 and M6 (during a follow-up visit by a pain specialist). 8.Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D). 9.Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate. 10.Pain management satisfaction scores (score from 0 to 10) at discharge. 11.Collection of serious adverse events between D0 (date of surgery) and D30. 12.Dose of intraoperative rescue remifentanil in the OFA group (mcg). ;Timepoint(s) of evaluation of this end point: 1.In intraoperative. 2.On arrival in the PACU (. 3.In the PACU, at D0, D1 and D2. 4.In the PACU, at D0, D1 and D2. 5.In the PACU (mg). 6.During the first 48 hours postoperatively. 7.On D2, D4, M1, M3 and M6. 8.In PACU (h) and discharge. 9.At discharge. 10.At discharge. 11.Between D0 and D30. 12.Intraoperative.	—

Measure

Time frame

Secondary end point(s): 1. Assessment of vasopressor requirement and total intraoperative filling volume. 2.Assessment of the state of consciousness on arrival in the PACU (S0 Awake, S1 Drowsy, responds to call, S2 Drowsy responds to touch, S3 non awake comatose). 3.Assessment of the incidence of PONV in the PACU, at D0, D1 and D2. 4.Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2. 5.Dose of morphine given in titration in the PACU (mg). 6.Number of boluses demand on PCA during the first 48 hours postoperatively. 7.DN4 score (Neuropathic Pain 4) on D2, D4, M1, M3 and M6 (during a follow-up visit by a pain specialist). 8.Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D). 9.Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate. 10.Pain management satisfaction scores (score from 0 to 10) at discharge. 11.Collection of serious adverse events between D0 (date of surgery) and D30. 12.Dose of intraoperative rescue remifentanil in the OFA group (mcg). ;Timepoint(s) of evaluation of this end point: 1.In intraoperative. 2.On arrival in the PACU (. 3.In the PACU, at D0, D1 and D2. 4.In the PACU, at D0, D1 and D2. 5.In the PACU (mg). 6.During the first 48 hours postoperatively. 7.On D2, D4, M1, M3 and M6. 8.In PACU (h) and discharge. 9.At discharge. 10.At discharge. 11.Between D0 and D30. 12.Intraoperative.

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Countries

France

Contacts

Public ContactDREH Pôle Promotion

Institut Curie

drci.promotion@curie.fr33147 11 16 57

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026