Multimodal Pain Management for Postoperative Pain

Overseen By William Kent, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Disqualifiers: Polytrauma, Severe systemic disease, Pregnancy, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage pain after orthopedic surgery by comparing two treatments. One group will receive the usual pain medication, hydrocodone-acetaminophen, while the other will use a combination of different pain relievers (multimodal pain management). The goal is to determine if the new method can effectively control pain while reducing the need for addictive opioids. People with an orthopedic injury requiring surgery at UCSD might be suitable candidates for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are participating in another study or your doctor has specific recommendations, it might affect your eligibility.

What is the safety track record for these treatments?

Research shows that combining different methods to manage pain is generally safe. Studies have found that this approach effectively reduces pain after surgery and decreases the need for opioids. For example, one study found that a plan using medications like ibuprofen, acetaminophen, gabapentin, and bupivacaine significantly reduced pain and led to shorter hospital stays. Another review noted that these combinations often result in better pain control and less need for opioids after surgery.

While these results are encouraging, all treatments can have side effects. However, evidence suggests that the side effects of using multiple methods for pain management are usually mild and manageable. Always discuss any concerns with the trial team to ensure you have all the necessary information. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about multimodal pain management for postoperative pain because it combines several medications to target pain in different ways. This approach uses a combination of ibuprofen, acetaminophen, gabapentin, and 0.25% bupivacaine, which work together to manage pain more effectively than standard opioid-based treatments like hydrocodone-acetaminophen. Unlike traditional methods that rely heavily on opioids, this treatment aims to reduce opioid consumption, potentially decreasing the risk of side effects and addiction. By addressing pain through multiple pathways, this strategy could lead to better pain control and a more comfortable recovery for patients.

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

This trial will compare two approaches to postoperative pain management. Research has shown that combining different pain relief methods, as in the multimodal pain post-op management arm of this trial, effectively manages pain after surgery and reduces the need for opioids. This approach uses various medications like ibuprofen, acetaminophen, gabapentin, and bupivacaine to significantly lower pain levels shortly after surgery and even 24 hours later. Specifically, one study found that this method can reduce the average daily use of opioids by about 60%. It is currently recommended for effective pain control after surgeries and offers a promising alternative to relying solely on opioids for pain management. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults aged 18+ who need orthopaedic surgery at UCSD and can consent to participate are eligible. Excluded are those with multiple injuries, severe diseases not managed medically, pregnant women or those planning pregnancy within a year, prisoners, recent substance abusers, and anyone in another drug study recently.

Inclusion Criteria

Evaluation and treatment at UCSD

I need surgery for a bone or joint injury.

Ability to understand the content of the patient information/Informed Consent Form

Exclusion Criteria

I have chosen a specific way to manage my pain.

Prisoner

Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Pain Management

Trial Overview The trial compares two pain management methods after orthopaedic surgery: a multimodal approach using Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine versus standard oral hydrocodone-acetaminophen. It's randomized and will assess opioid use, pain control, and function.

How Is the Trial Designed?

Group I: Standard oral hydrocodone-acetaminophen post-op management Active Control 1 Intervention

Group II: Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

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]

Effective management of post-operative pain can significantly improve patient recovery and reduce the risk of complications, highlighting the importance of thorough preoperative evaluations and individualized treatment plans.

Using a multimodal approach to pain management, which combines various analgesic techniques, can enhance pain relief while minimizing side effects, making it a promising strategy for optimizing post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating post-operative pain]. Blichfeldt-Eckhardt, MR., Jensen, JM., Møller, JF.[2018]

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]

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]

A multimodal analgesic approach, which combines various pain relief methods, is effective in improving postoperative pain management and reducing the need for opioids, but its implementation is not consistent across all practices.

An optimal regimen should include acetaminophen, non-steroidal anti-inflammatory drugs, dexamethasone, and regional analgesic techniques, while also considering patient education and non-pharmacological interventions, especially for those at high risk for postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rational Multimodal Analgesia for Perioperative Pain Management. Joshi, GP.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7999688/

Efficacy of Multimodal Analgesia for Postoperative Pain ... In conclusion, our data suggest MMA is an effective method of pain control and opioid reduction in patients undergoing surgery for head and neck ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12463453/

Multimodal Analgesia in the Perioperative Period of Major ... Meta-analysis indicates a significant reduction in pain scores at 0 hours, pain scores at 24 hours, and overall neuropathic pain [53]. In ...

3. link.springer.com link.springer.com/article/10.1007/s44254-023-00043-1

Perioperative multimodal analgesia: a review of efficacy ... Data thus far has suggested most of the efficacy for gabapentin use in the reduction of postoperative pain and opioid consumption, however, this ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818001003208

Multimodal analgesia for postoperative pain control This review focuses on multimodal analgesia, which is currently recommended for effective postoperative pain control.

5. thepermanentejournal.org thepermanentejournal.org/doi/10.7812/TPP/20.048

Implementation of a Post-Surgical, Multimodal Analgesia ... Average daily opioid consumption decreased approximately 60% after implementation of scheduled acetaminophen and scheduled gabapentin during the ...

6. ijssurgery.com ijssurgery.com/custom-print/43268

A Novel Multimodal Postoperative Pain Protocol for 1 Conclusion Our novel multimodal pain management protocol significantly reduced postoperative pain, length of stay, and opioid consumption in this patient cohort ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9042766/

Postoperative Multimodal Pain Management and Opioid ... Many multimodal pain management protocols offer improved pain control and decreased opioid consumption after arthroscopic surgery.