Non-opioid pain management after breast surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of non-opioid analgesia compared to traditional opioid analgesia for managing postoperative pain in patients undergoing breast surgery. It aims to address the opioid crisis by exploring alternative pain management strategies that do not involve opioid medications. The study will enroll patients who are scheduled for mastectomy or lumpectomy and will assess their pain levels and recovery outcomes based on the type of analgesia received. By focusing on opioid-free pain management, the trial seeks to reduce the risk of opioid misuse and dependency.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Undergoing mastectomy (i.e., total, modified radical, radical, or skin/nipple sparing) or lumpectomy (i.e., excisional biopsy, partial or segmental mastectomy, oncoplastic breast-conserving surgery) for malignant (cancer) and non-malignant diseases (i.e., ductal carcinoma in situ)
* Planned discharge on the day of the operation.

Exclusion Criteria:

* Immediate breast reconstruction, i.e., implant, tissue-expander, or autologous/flap-based (often leads to higher levels of pain and analgesia requirements)
* Contraindications to the drugs used in the trial in accordance with Health Canada Monographs (i.e., opioid use disorder, pregnancy, breastfeeding, heart failure, allergy/hypersensitivity, peptic ulcer, bleeding disorders, renal or liver impairment)
* Taking opioids preoperatively
* Cognitive impairment precluding patient-reported outcome assessment
* Need for postoperative hospitalization decided before randomization (i.e., same-day discharge cancelled for medical \[e.g., intra-operative complications\] or non-medical reasons \[e.g., lack of support at home\]).

Where it's running

• McGill University Health Centre (Glen Site)
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Julio Flavio Fiore, PhD — McGill University
• Study coordinator: Samin Shirzadi, MD, MPH
• Email: samin.shirzadi@rimuhc.ca
• Phone: 6475643377

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.