Status:
RECRUITING
Postoperative Analgesia Intervention With Non-opioid Alternatives (PAIN-Alt) Trial - Breast Surgery
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Post Operative Pain
Opioid Analgesic Adverse Reaction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
North America is experiencing a crisis of opioid use and abuse, partially caused by excessive prescribing by doctors. People often receive their first opioid prescription for pain treatment after outp...
Eligibility Criteria
Inclusion
- 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
- 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 \[e.g., lack of support at home\]).
Key Trial Info
Start Date :
November 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT06507345
Start Date
November 26 2024
End Date
February 28 2026
Last Update
January 13 2025
Active Locations (1)
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1
McGill University Health Centre (Glen Site)
Montreal, Quebec, Canada, H4A 3J1