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.
adult patients
breast cancer surgery (mastectomy, lumpectomy, with or without lymph node excision) under general anaesthesia
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)
Parallel
Opioid Free Anaesthesia (OFA)
Other interventionPatients are allocated to receive non-opioid anaesthesia intraoperatively. Patients will receive a mixture of dexmedetomidine, ketamine and lidocaine for intraoperative analgesia.
Conventional General Anaesthesia (CGA)
Other interventionPatients are allocated to receive conventional general anaesthesia intraoperatively with the use of fentanyl and morphine for intraoperative analgesia.
Postoperative analgesia.
Postoperative level of analgesia assessed by the NRS (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable).
Postoperative consumption of opioids.
Total postoperative consumption of opioids.
Perioperative blood pressure measurements.
Intermittent blood pressure measurements (every 5 minutes) - blood pressure measured in mmHg.
Perioparative pulse measurements.
Intermittent arterial pulse measurements (every 5 minutes) - measured in beats per minute.
Perioperative consumption of ephedrine.
Total intravenous consumption of ephedrine, measured in milligrams.
Perioperative consumption of atropine.
Total intravenous consumption of atropine, measured in milligrams.
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