Recruiting

Opioid-Free Analgesia vs. Opioid Analgesia

Sponsor:

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

Code:

NCT06507345

Conditions

Post Operative Pain

Opioid Analgesic Adverse Reaction

Surgery

Postoperative Pain

Breast Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs]

Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs]

Study Details

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 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

Post Operative Pain

Opioid Analgesic Adverse Reaction

Surgery

Postoperative Pain

Breast Disease

Study ID

NCT06507345

Start date

Nov 26, 2024

Status verified date

Jan, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 \[e.g., lack of support at home\]).

Study Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Opioid Analgesia (OA)

experimental: Opioid-Free Analgesia (OFA)

Interventions

Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs]

In line with current standard care, discharge prescriptions for this group will include around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs given at regularly scheduled intervals) and opioid tablets 'as needed' for breakthrough pain (i.e., pain that erupts while patients are already taking analgesics). Non-pharmacological pain interventions (i.e., icepacks, music, meditation.) may be recommended by some surgeons as part of standard practice. Given the pragmatic nature of the trial, the specific around-the-clock analgesia and rescue opioid regimens and other non-pharmacological interventions will be determined by the patient's surgeon discretion considering the breast procedure undertaken, co-morbidities, and patient preference.

Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs]

Discharge prescriptions for this group will include around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs). In case of breakthrough pain, rescue analgesia may be provided by (1) using evidence-based non-pharmacological pain interventions (i.e., icepacks, music, and meditation), (2) adding non-opioid drugs not included in the initial regimen, or (3) switching drugs targeting individual variances in analgesia response. The specific around-the-clock and rescue OFA regimens will be determined by the patient's surgeon considering the type of procedure, co-morbidities, and patient preference.

Primary outcome measure

  • Pain intensity [ Time Frame: Postoperative days 1 to 7. ]
  • Pain interference [ Time Frame: Postoperative days 1 to 7. ]

Central Contacts and Locations

Central contacts

Samin Shirzadi, MD, MPH

6475643377samin.shirzadi@rimuhc.ca

Karine Roversi, PhD

4384935427karine.roversi@rimuhc.ca

Locations

McGill University Health Centre (Glen Site)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Samin Shirzadi, MD, MPH

6475643377samin.shirzadi@rimuhc.ca

Karine Roversi, PhD

4384935427

More Information

Sponsor

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

Last update posted

Jan 13, 2025

Last verified

Jan, 2025

Keywords

  • Surgery
  • Postoperative analgesia
  • Breast surgery
  • Opioids
  • Postoperative pain
  • Postoperative care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-01-13.