Opioid vs Non-Opioid Pain Management for Postoperative Pain

Overseen By Mostafa Borahay, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Opioids

Disqualifiers: Chronic pain, Gastritis, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids. The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.

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 data supports the effectiveness of the treatment Non-opioid Pain Control Regimen, Multimodal Non-opioid Analgesia, Non-opioid Pain Management for postoperative pain?

Research shows that using a combination of different non-opioid pain relief methods can effectively manage pain after surgery and reduce the need for opioids, which are strong painkillers with a risk of addiction. ^{1 2 3 4 5}

Is non-opioid pain management safe for postoperative pain?

Non-opioid pain management is generally safe for postoperative pain when used correctly. Adverse events are rare, but some medications like α-2 agonists can cause temporary low blood pressure and slow heart rate, and gabapentinoids may cause drowsiness in certain patients. Regional anesthesia is also safe when performed by experienced professionals. ^{1 3 6 7 8}

How is the Non-opioid Pain Control Regimen different from other treatments for postoperative pain?

The Non-opioid Pain Control Regimen is unique because it uses a combination of different non-opioid medications to manage pain, which can reduce the need for opioids and their side effects. This approach, known as multimodal analgesia, aims to improve pain relief and patient comfort while minimizing the risks associated with opioid use. ^{1 3 9 10 11}

Research Team

Mostafa Borahay, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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 am 18 years old or older.

Exclusion Criteria

I have a history of stomach inflammation or bleeding.

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

I have been using opioids for more than three months.

Trial Timeline

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

Treatment Details

Interventions

• Non-opioid Pain Control Regimen (Other)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The association of multimodal analgesia and high-risk opioid discharge prescriptions in opioid-naive surgical patients. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Pilot study of a novel pain management strategy: evaluating the impact on patient outcomes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Nonopioid Adjuncts and Alternatives. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Post-Surgical, Multimodal Analgesia Pain Management Order Set in Opioid-Naive Patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pain Intensity in the First 96 Hours After Abdominal Surgery: A Prospective Cohort Study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Comparing Opioid Usage in Non-Intensive Care Unit Trauma Patients After Implementing Multimodal Analgesia Order Sets. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Multimodal analgesia for controlling acute postoperative pain. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety of treatment options available for postoperative pain. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Postoperative pain management and outcome after surgery. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Cost analysis applied to postoperative analgesia regimens: a comparison between parecoxib and propacetamol. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of postoperative pain for burn patients with intravenous analgesia in continuous perfusion using elastomeric infusors. [2013]