Opioid-Free vs Opioid Analgesia for Postoperative Pain (PAIN-Alt Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByJulio Flavio Fiore, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are taking opioids before the surgery, you cannot participate in the trial.
What data supports the effectiveness of the treatment Opioid-Free Analgesia (OFA) for postoperative pain?
Research suggests that Opioid-Free Analgesia (OFA) can lead to lower pain scores and fewer side effects compared to traditional opioid use after surgery. It has been shown to improve patient recovery and satisfaction while reducing healthcare costs.
12345Is opioid-free analgesia generally safe for humans?
Opioid-free analgesia (OFA) is generally considered safe and can reduce some side effects associated with opioids, like nausea and sedation, but more data is needed to fully understand its safety profile.
14567How does opioid-free analgesia (OFA) differ from opioid analgesia (OA) for postoperative pain management?
Opioid-free analgesia (OFA) is unique because it avoids the use of opioids entirely, reducing the risk of opioid addiction and side effects. Instead, it uses a combination of non-opioid medications and techniques, such as local anesthetics, NSAIDs (non-steroidal anti-inflammatory drugs), and other adjuvants, to manage pain effectively.
128910Eligibility Criteria
This trial is for patients having outpatient breast surgery (mastectomy or lumpectomy) for cancerous or non-cancerous conditions, with plans to go home the same day. It's not specified who can't join.Inclusion Criteria
I am having surgery for breast cancer or a non-cancerous breast condition.
I am expected to go home the same day as my surgery.
Participant Groups
The study compares post-surgery pain management: one group receives opioid drugs and the other gets only non-opioid alternatives. The focus is on pain control effectiveness and side effects of each method.
2Treatment groups
Experimental Treatment
Active Control
Group I: Opioid-Free Analgesia (OFA)Experimental Treatment1 Intervention
Group II: Opioid Analgesia (OA)Active Control1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
McGill University Health Centre (Glen Site)Montreal, Canada
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
Analysis of predictors of opioid-free analgesia for management of acute post-surgical pain in the United States. [2019]Utilization of opioid-free analgesia (OFA) for post-surgical pain is a growing trend to counter the risks of opioid abuse and opioid-related adverse drug events (ORADEs). However, utilization patterns of OFA have not been examined. In this study, we investigated the utilization patterns and predictors of OFA in a surgical population in the United States.
Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial. [2022]The overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain.
Evolving the management of acute perioperative pain towards opioid free protocols: a narrative review. [2020]Objective: Identification of pain as the fifth vital sign has resulted in over-prescription and overuse of opioids in the US, with addiction reaching epidemic proportions. In Europe, and more recently in the US, a shift has occurred with the global adoption of multimodal analgesia (MMA), which seeks to minimize perioperative opioid use. Improved functional outcomes and reduced healthcare utilization costs have been demonstrated with MMA, but wide scale use of opioids in pain management protocols continues. As a next step in the pain management evolution, opioid-free analgesia (OFA) MMA strategies have emerged as feasible in many surgical settings.Methods: Articles were limited to clinical studies and meta-analyses focusing on comparisons between opioid-intensive and opioid-free/opioid-sparing strategies published in English.Results: In this review, elimination or substantial reduction in opioid use with OFA strategies for perioperative acute pain are discussed, with an emphasis on improved pain control and patient satisfaction. Improved functional outcomes and patient recovery, as well as reduced healthcare utilization costs, are also discussed, along with challenges facing the implementation of such strategies.Conclusions: Effective MMA strategies have paved the way for OFA approaches to postoperative pain management, with goals to reduce opioid prescriptions, improve patient recovery, and reduce overall healthcare resource utilization and costs. However, institution-wide deployment and adoption of OFA is still in early stages and will require personalization and better management of patient expectations.
Is Opioid-Free General Anesthesia More Superior for Postoperative Pain Versus Opioid General Anesthesia in Laparoscopic Cholecystectomy? [2022]Opioid-free anesthesia (OFA) is a new anesthesiological technique, where the giving of opioids (fentanyl) is avoided in the intra- and post-operative period. This leads to reduction in the opioid-related side effects and lower pain scores in the postoperative period.
POFA trial study protocol: a multicentre, double-blind, randomised, controlled clinical trial comparing opioid-free versus opioid anaesthesia on postoperative opioid-related adverse events after major or intermediate non-cardiac surgery. [2019]Reducing opioid consumption during and after surgery has been recommended for more than 10 years. Opioid-free anaesthesia (OFA) is a multimodal anaesthesia associating hypnotics, NMDA antagonists, local anaesthetics, anti-inflammatory drugs and α-2 agonists. Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesised that the reduced opioid consumption allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.
Opioid-Free Anesthesia Benefit-Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]Opioid-free anesthesia (OFA) is used in surgery to avoid opioid-related side effects. However, uncertainty exists in the balance between OFA benefits and risks. We searched for randomized controlled trials (RCTs) comparing OFA to opioid-based anesthesia (OBA) in five international databases. The co-primary outcomes were postoperative acute pain and morphine consumption at 2, 24, and 48 h. The secondary outcomes were the incidence of postoperative chronic pain, hemodynamic tolerance, severe adverse effects, opioid-related adverse effects, and specific adverse effects related to substitution drugs. Overall, 33 RCTs including 2209 participants were assessed. At 2 h, the OFA groups had lower pain scores at rest MD (0.75 (-1.18; -0.32)), which did not definitively reach MCID. Less morphine was required in the OFA groups at 2 and 24 h, but with very small reductions: 1.61 mg (-2.69; -0.53) and -1.73 mg (p < 0.05), respectively, both not reaching MCID. The reduction in PONV in the OFA group in the PACU presented an RR of 0.46 (0.38, 0.56) and an RR of 0.34 (0.21; 0.56), respectively. Less sedation and shivering were observed in the OFA groups with an SMD of -0.81 (-1.05; -0.58) and an RR of 0.48 (0.33; 0.70), respectively. Quantitative analysis did not reveal differences between the hemodynamic outcomes, although severe side effects have been identified in the literature. No clinically significant benefits were observed with OFA in terms of pain and opioid use after surgery. A clear benefit of OFA use was observed with respect to a reduction in PONV. However, more data on the safe use of OFAs should be collected and caution should be taken in the development of OFA.
Opioid-free anesthesia reduces the severity of acute postoperative motion-induced pain and patient-controlled epidural analgesia-related adverse events in lung surgery: randomized clinical trial. [2023]Opioids have been used as pain relievers for thousands of years. However, they may also cause undesirable side effects. We therefore performed this study to compare the effect of opioid-free anesthesia (OFA) versus opioid-sparing anesthesia (OSA) on postoperative pain and patient-controlled epidural analgesia (PCEA)-related events.
Is Intraoperative Opioids Avoidance A Utopia? A Matched Study in Laparoscopic Hysterectomy. [2022]Opioid-sparing strategies are recommended, and Opioid-Free Anaesthesia (OFA) is proposed in the literature. But few data exist about the feasibility of OFA in the routine practice. From a larger series of 21,463 patients receiving OFA, this work investigates the postoperative pain and related outcomes in patients undergoing laparoscopic hysterectomy.
Lessons from the Analysis of a Retrospective Cohort of Patients Who Underwent Large Open Abdominal Surgery Under Total Intravenous Opioid-Free Anesthesia. [2021]Opioid-free anesthesia (OFA) is a new method of anesthesia based on a paradigm shift. Under general anesthesia, the physiology and/or the pathophysiological variations clinically observed are more a reflection of a systemic reaction to the stress (surgical and anesthesia stresses) than a true reflection of pain.
Special indications for Opioid Free Anaesthesia and Analgesia, patient and procedure related: Including obesity, sleep apnoea, chronic obstructive pulmonary disease, complex regional pain syndromes, opioid addiction and cancer surgery. [2018]Opioid-free anaesthesia (OFA) is a technique where no intraoperative systemic, neuraxial or intracavitary opioid is administered with the anaesthetic. Opioid-free analgesia similarly avoids opioids in the perioperative period. There are many compelling reasons to avoid opioids in the surgical population. A number of case reports and, increasingly, prospective studies from all over the world support its benefits, especially in the morbidly obese population with or without sleep apnoea. A derivative technique is opioid sparing, where the same techniques are used but some opioid use is allowed. This chapter is a review of the current knowledge regarding opioid-free or low-dose opioid anaesthetic and analgesic techniques for the following special populations: obesity, sleep apnoea, chronic obstructive pulmonary disease, complex regional pain syndromes, acute/chronic opioid addiction and cancer surgery. Practical aspects include sympatholysis, analgesia and Minimum Alveolar Concentration (MAC) reduction with dexmedetomidine; analgesia with low-dose ketamine and co-anaesthesia; and sympatholysis with intravenous lignocaine. Non-opioid adjuvants such as NSAIDS, paracetamol, magnesium, local anaesthetic infiltration and high-dose steroids are added in the perioperative period to further achieve co-analgesia. Loco-regional anaesthesia and analgesia are also maximised. It remains to be seen whether OFA and early postoperative analgesia, which similarly avoids opioids, can prevent the development of hyperalgesia and persistent postoperative pain syndromes.