Opioid-free Anaesthesia in Breast Cancer Surgery
Recruiting now · Not applicable
Conditions studied: Breast Cancer, Anesthesia, Pain, Postoperative, Pain, Chronic, Opioid Free Anaesthesia, Cancer Recurrence
In brief
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.
Key facts
- Study ID
- NCT06404983
- Run by
- University of Ioannina
- People needed
- 200
- Starts
- 2022-12-28
- Expected to finish
- 2027-09-12
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- adult patients
- breast cancer surgery (mastectomy, lumpectomy, with or without lymph node excision) under general anaesthesia
You may not qualify if…
- 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
Where it is running
- University Hospital of Ioannina — Ioannina, Epirus, Greece (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.