A Comparative Evaluation of Opioid Free Anaesthesia Technique Versus the Conventional Technique in Oncological Breast Surgery

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• adult patients

• breast cancer surgery (mastectomy, lumpectomy, with or without lymph node excision) under general anaesthesia

Locations
Other Locations
Greece
University Hospital of Ioannina
RECRUITING
Ioannina
Contact Information
Primary
Agathi Karakosta
akarakosta@uoi.gr
+306948066243
Backup
Gloria-Evdoxia Izountouemoi
gloriaizou@gmail.com
+306982799750
Time Frame
Start Date: 2022-12-28
Estimated Completion Date: 2027-09-12
Participants
Target number of participants: 200
Treatments
Experimental: Opioid Free Anaesthesia (OFA group)
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.
Active_comparator: Conventional general anaesthesia (CGA group)
Patients are randomly allocated to receive conventional general anaesthesia with intraoperative use of opioids at the discretion of the attending anaesthesiologist.
Sponsors
Leads: University of Ioannina

This content was sourced from clinicaltrials.gov

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