Opioid-free Anaesthesia in Breast Cancer Surgery

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.

Conditions

• Breast Cancer
• Anesthesia
• Pain, Postoperative
• Pain, Chronic
• Opioid Free Anaesthesia
• Cancer Recurrence

Interventions

OTHER

Opioid Free Anaesthesia (OFA)

Patients are allocated to receive non-opioid anaesthesia intraoperatively. Patients will receive a mixture of dexmedetomidine, ketamine and lidocaine for intraoperative analgesia.

OTHER

Conventional General Anaesthesia (CGA)

Patients are allocated to receive conventional general anaesthesia intraoperatively with the use of fentanyl and morphine for intraoperative analgesia.

Sponsors & Collaborators

• University of Ioannina

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-28

Primary Completion

2026-12-20

Completion

2027-09-12

Countries

• Greece

Study Locations