Opioid-free Anaesthesia in Breast Cancer Surgery

NCT06404983 | Recruiting

• 1 other identifier: 27
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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).

  From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.

• Postoperative consumption of opioids.

  Total postoperative consumption of opioids.

  From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.

Secondary Outcomes (17)

• Perioperative blood pressure measurements.

  From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.

• Perioparative pulse measurements.

  From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.

• Perioperative consumption of ephedrine.

  From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.

• Perioperative consumption of atropine.

  From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.

• Perioperative consumption of phenylephrine.

  From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.

Study Arms (2)

Opioid Free Anaesthesia (OFA group)

EXPERIMENTAL

Patients are randomly allocated to receive non-opioid anaesthesia. Intraoperative analgesia will be achieved by continuous intravenous administration of a mixture of dexmedetomidine, ketamine, and lidocaine.

Other: Opioid Free Anaesthesia (OFA)

Conventional general anaesthesia (CGA group)

ACTIVE COMPARATOR

Patients are randomly allocated to receive conventional general anaesthesia with intraoperative use of opioids at the discretion of the attending anaesthesiologist.

Other: Conventional General Anaesthesia (CGA)

Interventions

Conventional General Anaesthesia (CGA) OTHER

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

Also known as: O.A.M. (Opioid Anaesthetic Mixtute: fentanyl, morphine)

Conventional general anaesthesia (CGA group)

Opioid Free Anaesthesia (OFA) OTHER

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

Also known as: N.O.A.M (non-opioid anaesthetic mixture: dexmedetomidine, ketamine and lidocaine)

Opioid Free Anaesthesia (OFA group)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Epirus, 455 00, Greece

RECRUITING

Related Publications (1)

• Wang K, Yee C, Tam S, Drost L, Chan S, Zaki P, Rico V, Ariello K, Dasios M, Lam H, DeAngelis C, Chow E. Prevalence of pain in patients with breast cancer post-treatment: A systematic review. Breast. 2018 Dec;42:113-127. doi: 10.1016/j.breast.2018.08.105. Epub 2018 Sep 4.

  PMID: 30243159 BACKGROUND

Related Links

• Opioid free anaesthesia (OFA) a Paradigm shift? (Mulier JP)

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Chronic Pain

Interventions

Ketamine; Lidocaine; Morphine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Agathi Karakosta

CONTACT

+306948066243; akarakosta@uoi.gr

Gloria-Evdoxia Izountouemoi

CONTACT

+306982799750; gloriaizou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesiology

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: May 8, 2024
• Study Start: December 28, 2022
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): September 12, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 months after publication and for a year afterwards.

Locations

GR (1)