Opioid vs Non-Opioid Pain Management for Postoperative Pain

Overseen By Mostafa Borahay, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must not be taking: Opioids

Disqualifiers: Chronic pain, Gastritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of non-opioid pain management compared to opioid-based pain management after a tubal sterilization procedure. Researchers aim to determine if methods like Tylenol and Ibuprofen alone can effectively manage pain without opioids. Participants will be divided into two groups: one receiving opioids and the other receiving only non-opioid medications post-surgery. This trial suits individuals undergoing a tubal sterilization procedure for non-cancerous reasons who do not have chronic pain conditions and are not on long-term opioid therapy. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on long-term opioid use. It's best to discuss your current medications with the study team.

What is the safety track record for these treatments?

Studies have shown that non-opioid pain relievers can be very effective and usually have fewer side effects than opioids. Non-opioid medications, such as Tylenol (acetaminophen) and Ibuprofen, are easy to tolerate and commonly manage pain. Research indicates that these drugs can reduce the need for opioids after surgery by targeting different pain pathways, often resulting in fewer side effects.

Additionally, non-opioid pain relief methods are generally considered safe, with most people not experiencing serious side effects. These medications have been safely used in many patients and are often part of a multimodal approach, where different types of pain relievers are combined for better results.

Overall, non-opioid pain management is usually safe and effective, especially when combined with education on pain management and expectations. While some patients might still need opioids, starting with non-opioid options can reduce this need. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the trial comparing opioid and non-opioid pain management for postoperative pain because it explores minimizing opioid use, which is a standard but often problematic treatment due to its potential for addiction and side effects. The non-opioid regimen, which uses only Tylenol and Ibuprofen, aims to effectively manage pain without the risks associated with opioids. If successful, this approach could offer a safer pain management strategy after surgeries, reducing reliance on opioids and potentially transforming postoperative care.

What evidence suggests that this trial's treatments could be effective for postoperative pain management?

This trial will compare opioid and non-opioid pain management strategies for postoperative pain. Research has shown that combining different methods for pain relief, known as multimodal analgesia, effectively reduces pain after surgery. Participants in Arm 2 of this trial will receive a non-opioid regimen, combining medications like Tylenol and Ibuprofen. Studies have found that this approach can greatly decrease the need for opioids. These treatments address different pain pathways, helping to ease discomfort and lessen opioid-related side effects. Non-opioid treatments have managed pain well and improved recovery, such as enhancing bowel function. Overall, non-opioid pain management offers a promising alternative to opioids for postoperative care. ^{2 3 4 5 6}

Who Is on the Research Team?

Mostafa Borahay, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for women who have undergone a minimally invasive procedure to remove their fallopian tubes (laparoscopic salpingectomy) and are experiencing post-operative pain. Participants should not currently be struggling with opioid misuse or have conditions that would interfere with the study.

Inclusion Criteria

I am having a laparoscopic or robotic surgery to remove my fallopian tubes.

Agreeing to participate

I have at least one fallopian tube.

Exclusion Criteria

I have a history of stomach inflammation or bleeding.

I had surgery to remove my fallopian tube due to an ectopic pregnancy.

My surgery was changed to an open procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive tubal sterilization procedures and receive either an opioid or non-opioid post-operative pain regimen

1 week

1 visit (in-person) for the procedure

Follow-up

Participants are monitored for post-operative pain scores and satisfaction with pain relief and mobility

1 week

2 surveys (virtual) on post-operative day 1 and day 7

Extended Follow-up

Participants are monitored for additional pain medication requests and opioid-related side effects

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-opioid Pain Control Regimen

Trial Overview

The study is testing if a combination of non-opioid pain relievers like Acetaminophen and Ibuprofen can manage pain just as well as including an opioid (Oxycodone) in the treatment plan after tubal sterilization surgery.

How Is the Trial Designed?

Group I: Arm 2 - Non-Opioid Post-Op Pain Regimen Experimental Treatment 2 Interventions

Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows: Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter. Participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1.

Group II: Arm 1 - Opioid Post-Op Pain Regimen Active Control 3 Interventions

Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge. These medications include: Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A multimodal approach to postoperative pain management, combining regional analgesic techniques with non-opioid agents, can effectively reduce opioid use and improve patient comfort, potentially leading to better recovery outcomes.

Epidural analgesia provides strong pain relief and may enhance recovery of bowel function and rehabilitation, but it has not been shown to significantly reduce postoperative morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management and outcome after surgery. Bonnet, F., Marret, E.[2022]

Multimodality nonopioid analgesia has been shown to be effective for managing pain, suggesting it can be a valuable alternative to opioids.

The decision to use opioids or nonopioids for pain control should be guided by a careful assessment of the risks and benefits associated with each treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonopioid Adjuncts and Alternatives. Husain, Q., Banks, C., Gray, ST.[2021]

The implementation of a multimodal analgesia order set did not significantly reduce opioid consumption in trauma patients, with oral morphine equivalents remaining similar before and after the intervention (21.3 vs. 18.8 OME).

Despite the unchanged opioid usage, pain scores remained stable, indicating that multimodal analgesia may still be beneficial in managing pain without increasing opioid reliance, even with more surgical procedures performed in the later cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Opioid Usage in Non-Intensive Care Unit Trauma Patients After Implementing Multimodal Analgesia Order Sets. Brenneman, R., Mostafavifar, L., Magrum, B., et al.[2022]

In a study of 1,278 patients undergoing various abdominal surgeries, pain was generally well-controlled postoperatively, with average pain scores below 3 on a scale of 0-10, leading to high patient satisfaction (mean score of 8.18).

Younger patients (under 70 years) were identified as the only independent risk factor for experiencing moderate to severe pain (VAS ≥ 4), suggesting that targeted preventive pain management strategies may be beneficial for this age group, especially during mobilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Intensity in the First 96 Hours After Abdominal Surgery: A Prospective Cohort Study. Cachemaille, M., Grass, F., Fournier, N., et al.[2021]

In a study of 182 patients undergoing inguinal hernia surgery, intravenous parecoxib resulted in higher patient satisfaction (87%) compared to intravenous propacetamol (70%) for postoperative pain management.

Although parecoxib had a higher average cost per patient (€6.65 vs €5.28 for propacetamol), the incremental cost per additional patient satisfied was only slightly higher (€8.02), suggesting that parecoxib may provide better value in terms of patient satisfaction despite its higher cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost analysis applied to postoperative analgesia regimens: a comparison between parecoxib and propacetamol. Tilleul, P., Weickmans, H., Sean, PT., et al.[2018]

Nonsteroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitors effectively reduce the need for opioids after surgery, which is crucial for improving recovery outcomes.

While some adjuvant medications like NMDA antagonists and alpha-2 adrenergic agonists show variable effectiveness, gabapentin and local anesthetic injections at the surgical site have shown promise in enhancing multimodal analgesia strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal analgesia for controlling acute postoperative pain. Buvanendran, A., Kroin, JS.[2022]

The novel multimodal pain management strategy significantly reduced intraoperative opioid requirements, with experimental patients receiving an average of 158 mcg of fentanyl compared to 299 mcg in the control group (p < 0.01).

Patients in the experimental group experienced lower postoperative pain scores and shorter hospital stays (3.0 days vs. 4.1 days, p = 0.04), indicating improved recovery outcomes without increasing complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a novel pain management strategy: evaluating the impact on patient outcomes. Keller, DS., Tahilramani, RN., Flores-Gonzalez, JR., et al.[2022]

Multimodal analgesia that minimizes opioid use after surgery can reduce postoperative pain and the risk of complications, highlighting the importance of using non-opioid analgesics like NSAIDs, gabapentinoids, and regional anesthesia techniques.

Non-opioid analgesics generally have a low risk of adverse events when used appropriately, although certain medications like α-2 agonists and gabapentinoids may have specific risks, emphasizing the need for standardized protocols to enhance patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of treatment options available for postoperative pain. Jin, Z., Lee, C., Zhang, K., et al.[2021]

A study of 32,511 opioid-naïve surgical patients showed that the use of multimodal analgesia increased significantly from 2012 to 2018, leading to a decrease in high-risk opioid prescriptions at discharge from 34.1% to 17.7%.

Despite improvements in pain management, about 20% of patients still received high-risk opioid prescriptions, indicating that careful consideration of pre-discharge opioid use and multimodal analgesia is essential for safe prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of multimodal analgesia and high-risk opioid discharge prescriptions in opioid-naive surgical patients. Langnas, E., Rodriguez-Monguio, R., Luo, Y., et al.[2023]

Implementing a multimodal analgesia pain management order set significantly reduced opioid consumption in opioid-naive patients after general surgery, with average daily opioid use dropping from 53.6 to 21.2 oral morphine equivalents on the first postoperative day.

Despite the reduction in opioid use, patient-reported pain scores remained similar before and after the implementation, indicating effective pain management without increasing discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Post-Surgical, Multimodal Analgesia Pain Management Order Set in Opioid-Naive Patients. Brown, F., Guinta, M., Swindler, J., et al.[2022]

Continuous intravenous analgesia with morphine using elastomeric infusors provided effective pain relief for burn patients post-surgery, achieving a visual analog scale (VAS) score of less than 3 within 2 hours of starting treatment.

The method demonstrated a low incidence of side effects compared to traditional morphine delivery methods, with high patient satisfaction, suggesting it is a safe and efficient option for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of postoperative pain for burn patients with intravenous analgesia in continuous perfusion using elastomeric infusors. García Barreiro, J., Rodriguez, A., Cal, M., et al.[2013]

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Alternative and non-opioid options for pain management are necessary in perioperative patient care. Opioids are no longer touted as cure-all medications.