Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06507345

Postoperative Analgesia Intervention With Non-opioid Alternatives (PAIN-Alt) Trial - Breast Surgery

Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-01-13

540

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

Sponsors

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 outpatient breast surgery (i.e., surgery to remove all or parts of the breast(s), where patients leave the hospital the same day). Many patients misuse these drugs and become addicted. Additionally, many of the opioid pills prescribed to patients are left unused and may be misused by family members, friends, or other community members. To prevent this problem, surgeons can avoid prescribing opioids by prioritizing opioid-free analgesia (i.e., pain treatment using only non-opioid interventions). Prescribing only non-opioid pain medications after surgery is very common in many countries outside of North America; however, few studies have assessed whether opioid-free analgesia is as effective as opioid analgesia after breast surgery. Therefore, the main question driving this study is: For patients who undergo outpatient breast surgery, is pain treatment without opioids as good as pain treatment with opioids? The proposed trial will compare two groups of patients: one group will receive opioids to treat pain after surgery, while the other group will receive only non-opioid medications. The impact of these different medication strategies will be measured on pain intensity, pain interference with daily activities, medication side effects, and other outcomes. An expert team of scientists, surgeons, pain specialists, nurses, and patients has been assembled to maximize the success of this study. The results will provide important information to guide surgeons' decisions to prescribe (or not to prescribe) opioids. If opioid-free analgesia is found to be effective, doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people from misusing opioids.

CONDITIONS

Official Title

Postoperative Analgesia Intervention With Non-opioid Alternatives (PAIN-Alt) Trial - Breast Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing mastectomy (total, modified radical, radical, or skin/nipple sparing) or lumpectomy (excisional biopsy, partial or segmental mastectomy, oncoplastic breast-conserving surgery) for cancerous or non-cancerous breast disease
  • Planned discharge on the day of the operation
Not Eligible

You will not qualify if you...

  • Immediate breast reconstruction with implant, tissue-expander, or autologous/flap-based surgery
  • Contraindications to trial drugs including opioid use disorder, pregnancy, breastfeeding, heart failure, allergy/hypersensitivity, peptic ulcer, bleeding disorders, renal or liver impairment
  • Taking opioids before surgery
  • Cognitive impairment preventing patient-reported outcome assessment
  • Need for postoperative hospitalization before randomization due to medical or non-medical reasons

AI-Screening

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Trial Site Locations

Total: 1 location

1

McGill University Health Centre (Glen Site)

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

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Research Team

S

Samin Shirzadi, MD, MPH

CONTACT

K

Karine Roversi, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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