NCT06404983 Opioid-free Anaesthesia in Breast Cancer Surgery
| NCT ID | NCT06404983 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ioannina |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-12-28 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-12-28 with a primary completion date of 2026-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Various analgesic modalities are adopted for perioperative analgesia in breast cancer surgeries. Opioid-free and opioid-sparing techniques are gaining popularity due to the lack of opioid-dependent undesirable effects, including respiratory depression, urinary retention, nausea and vomiting, constipation, itching, opioid-induced hyperalgesia, tolerance, addiction, and immune system disorders. The goal of this prospective randomized clinical trial is to investigate the impact of opioid-free anaesthesia (OFA) versus conventional general anaesthesia (CGA) on postoperative analgesic requirements after breast cancer surgery (lumpectomy/mastectomy, with or without axillary lymph node excision). Secondary objectives include comparative perioperative evaluation of cognitive function and postoperative adverse events during the first 48 hours atfter surgery. Comparative evaluation of intraoperative haemodynamics and hospital length of stay are also secondary objectives, as well as the incidence of neuropathic pain assessed by validated questionnaires at 3 and 6 months postoperatively. During the preoperative screening, body measurements, age, gender, ASA (American Society of Anesthesiologists) physical status classification, educational level (using a 6-level scale: elementary, middle school, high school, higher education, higher education, and postgraduate/doctoral degree), home medication, and comorbidities (using the Charlson Comorbidity Index) are recorded. Intraoperatively, the duration of anaesthesia, duration of surgery, associated intraoperative data (e.g., haemodynamic instability, adverse effects associated with protocol-administered pharmaceutical agents, etc.), and medications administered (type and quantity) are recorded. The investigators expect to recruit at least 100 participants per group.
Eligibility Criteria
Inclusion Criteria: * adult patients * breast cancer surgery (mastectomy, lumpectomy, with or without lymph node excision) under general anaesthesia Exclusion Criteria: * under 18 years * patient refusal * opioid use (systemic or not) for any reason (e.g., chronic malignant pain) * language barrier (difficulty in communicating in Greek language) * allergy to the administered agents * severe arrhythmia or other serious cardiac disease * severe liver and kidney failure * dementia, psychiatric diseases, and/or preoperative cognitive impairment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06404983 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06404983 currently recruiting?
Yes, NCT06404983 is actively recruiting participants. Contact the research team at akarakosta@uoi.gr for enrollment information.
Where is the NCT06404983 trial being conducted?
This trial is being conducted at Ioannina, Greece.
Who is sponsoring the NCT06404983 clinical trial?
NCT06404983 is sponsored by University of Ioannina. The trial plans to enroll 200 participants.
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