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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery 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 data supports the effectiveness of the treatment Multimodal Pain Management for postoperative pain?

Research shows that using multimodal pain management, which combines different methods to control pain, can improve pain relief after surgery and reduce the need for opioids, which are strong painkillers with potential side effects. ^{1 2 3 4 5}

Is multimodal pain management generally safe for humans?

Multimodal pain management is widely used for postoperative pain and is considered safe, but there are safety concerns related to aggressive use and system-based gaps in acute pain medicine services. ^{1 5 6 7 8}

How is multimodal pain management different from other treatments for postoperative pain?

Multimodal pain management is unique because it combines different pain relief methods to enhance their effects and minimize side effects, unlike traditional treatments that often rely on a single type of pain relief. This approach can improve pain control and reduce the need for opioids, which are commonly used but have significant side effects. ^{1 3 7 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

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

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

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

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

Rational Multimodal Analgesia for Perioperative Pain Management. [2023]

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

Multimodal pain management in orthopedics: implications for joint arthroplasty surgery. [2022]

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

Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. [2022]

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

Multimodal analgesia for controlling acute postoperative pain. [2022]

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

Efficacy of Liposomal Bupivacaine for Sternotomy Pain After Cardiac Surgery: A Retrospective Analysis. [2022]

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

Safety in Acute Pain Medicine-Pharmacologic Considerations and the Impact of Systems-Based Gaps. [2019]

9. India pubmed.ncbi.nlm.nih.gov

The Effect of Gabapentin Plus Celecoxib on Pain and Associated Complications After Laminectomy. [2022]

10. Denmark pubmed.ncbi.nlm.nih.gov

[Treating post-operative pain]. [2018]