Non-opioid pain management after breast surgery
Comparative Effectiveness of Opioid Versus Opioid-free Post-discharge Analgesia After Outpatient Breast Surgery: A Protocol for a Randomized Controlled Trial (PAIN-Alt Trial)
This study is testing whether non-opioid pain relief can help people recovering from breast surgery feel better and heal without using traditional opioid medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06507345 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing mastectomy or lumpectomy for both malignant and non-malignant breast diseases who are planned for same-day discharge.
Not a fit: Patients requiring immediate breast reconstruction or those with contraindications to the trial medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid prescriptions and associated risks for patients undergoing breast surgery.
How similar studies have performed: Other studies have shown promising results with non-opioid analgesia in various surgical settings, suggesting potential success for this approach in breast surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montreal, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.