Multimodal Pain Package for Post-Spinal Surgery Pain Management

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Yiliam Yiliam, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: University of Miami

Must be taking: Pain control analgesics

Must not be taking: Narcotics, Gabapentins, NSAIDs, others

Disqualifiers: Pregnancy, Liver disease, Kidney disease, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using narcotics, gabapentins, or chronic steroids. If you have allergies to certain medications like NSAIDs or Tylenol, you also cannot join.

What data supports the effectiveness of the Multimodal Pain Package treatment for post-spinal surgery pain management?

Research shows that using a combination of pain relief methods, like paracetamol with anti-inflammatory drugs and opioids, can enhance pain management and reduce side effects. This approach has been effective in other surgeries, such as hip replacements, and can improve pain relief and patient satisfaction after surgeries like lumbar disc surgery. ^{1 2 3 4 5}

Is the Multimodal Pain Package generally safe for humans?

Research shows that using a combination of pain medications like paracetamol (also known as acetaminophen), NSAIDs (non-steroidal anti-inflammatory drugs), and tramadol in multimodal pain management is generally safe and can effectively reduce pain with fewer side effects. These combinations have been used safely in various surgeries, including knee and vascular surgeries, to manage pain without relying heavily on stronger narcotics. ^{1 4 6 7 8}

How is the Multimodal Pain Package drug different from other pain management drugs for post-spinal surgery?

The Multimodal Pain Package is unique because it combines different types of pain relief medications, like NSAIDs (non-steroidal anti-inflammatory drugs), acetaminophen, and opioids, to manage pain through multiple mechanisms, reducing the need for high doses of any single drug and minimizing side effects. This approach is particularly beneficial in reducing opioid consumption and improving recovery after spine surgery. ^{4 7 8 9 10}

Research Team

Yiliam Yiliam, MD

Principal Investigator

Professor of Clinical

Eligibility Criteria

This trial is for adults needing pain management after outpatient spinal surgeries like microdiscectomies. Candidates must not be pregnant, have severe liver or moderate to severe kidney disease, impaired lung function, allergies to specific drugs (sulfonamides, NSAIDs, aspirin), or conditions preventing same-day discharge.

Inclusion Criteria

I am an adult and not pregnant.

I am having a minor spine surgery and need medication for pain relief.

Exclusion Criteria

I have COPD with reduced lung function.

Current use of narcotics

Allergy to Gabapentins

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a multimodal medication pre-formulated package or standard-of-care medication in different bottles for 7 days

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Multimodal Pain Package (Other)
• Regular Formulation (Other)

Trial Overview The study compares a multimodal pain package including Decadron, Gabapentin, Famotidine, Oxycodone and Celebrex with regular formulations for managing post-surgical pain in patients who've had certain spinal procedures.

Participant Groups

Group I: Multi-Modal regimen Group Experimental Treatment 6 Interventions

Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.

Group II: Bottled pain formulations Group Active Control 6 Interventions

Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.

Multimodal Pain Package is already approved in Canada for the following indications:

Approved in Canada as Multimodal Pain Management for:

• Pain management in spinal surgeries
• Postoperative pain management in outpatient settings

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Findings from Research

Paracetamol is effective in enhancing multimodal analgesia, which combines different drugs and techniques to improve pain relief while reducing side effects, particularly important for the elderly population.

Strong preclinical evidence shows that paracetamol works well with other pain medications, such as anti-inflammatory and opioid drugs, making it a valuable option in both acute and chronic pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracetamol for multimodal analgesia. Freo, U.[2022]

Multimodal analgesia, which combines different types of pain relief methods, effectively manages postoperative pain while reducing the need for opioids and their side effects.

Using adjuncts like acetaminophen, anti-inflammatories, and gabapentinoids, along with techniques like local anesthetic infiltration and nerve blocks, can significantly enhance pain control and improve patient mobility after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal analgesia for hip arthroplasty. Tang, R., Evans, H., Chaput, A., et al.[2018]

A single oral dose of dexketoprofen (25 mg) combined with tramadol (75 mg) provided significant pain relief for 66% of participants in acute postoperative pain, compared to only 32% with placebo, indicating a number needed to treat (NNT) of 3.0, which is comparable to other effective analgesics.

The combination of dexketoprofen and tramadol had a low incidence of adverse events, primarily mild to moderate nausea and dizziness, suggesting it is a safe option for pain management in postoperative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fixed-dose oral dexketoprofen plus tramadol for acute postoperative pain in adults. Derry, S., Cooper, TE., Phillips, T.[2023]

In a study of 172 patients undergoing major orthopedic surgery, intramuscular dexketoprofen trometamol (50 mg) significantly reduced the need for morphine compared to placebo, demonstrating an effective opioid-sparing effect.

Patients receiving dexketoprofen reported lower pain intensity scores than those on placebo, indicating its strong analgesic efficacy, while no significant differences in wound bleeding were observed among the treatment groups, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of analgesic efficacy and morphine-sparing effect of intramuscular dexketoprofen trometamol with ketoprofen or placebo after major orthopaedic surgery. Hanna, MH., Elliott, KM., Stuart-Taylor, ME., et al.[2022]

In a study of 63 patients undergoing lumbar disc surgery, the combination of paracetamol and metamizole provided significantly better early postoperative pain relief compared to paracetamol alone, particularly noted at 30 minutes post-surgery.

Patient satisfaction was higher in the group receiving the paracetamol-metamizole combination, indicating that this regimen may enhance the overall experience of pain management without increasing total morphine consumption or side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The addition of metamizole to morphine and paracetamol improves early postoperative analgesia and patient satisfaction after lumbar disc surgery. Uzun, S., Aycan, IO., Erden, IA., et al.[2013]

In a phase III study involving 277 patients with moderate-to-severe acute low back pain, the fixed combination of 75 mg tramadol and 650 mg paracetamol (DDS-06C) significantly reduced pain intensity compared to placebo, with a median pain intensity difference of -6.0 versus -4.0 (p=0.038).

DDS-06C was well-tolerated, with 38% of patients experiencing mild-to-moderate adverse events, the most common being nausea, dizziness, vomiting, and somnolence, indicating a favorable safety profile for this combination analgesic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain. Lasko, B., Levitt, RJ., Rainsford, KD., et al.[2013]

In a study of 53 patients who underwent surgeries on the aorta and lower extremities, various combinations of non-narcotic analgesics were evaluated for effective postoperative pain relief, showing that multimodal regimens can provide good analgesia without narcotics.

The combination of paracetamol with tramadol not only led to a quicker onset of pain relief but also reduced the need for tramadol, making it a safer option for patients at high risk for complications from non-steroidal anti-inflammatory drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systemic multimodality postoperative analgesia in vascular surgery]. Kazennov, VV., Shishkin, MN., Amerov, DB.[2019]

Maximal multimodal analgesia, which involves using three or more analgesic agents, significantly reduces postoperative pain scores at rest for patients undergoing spinal surgery, with an average mean difference of -1.03 at 24 hours post-surgery.

Patients receiving maximal multimodal analgesia also experienced a shorter hospital stay, with a mean difference of -0.55 days, indicating improved recovery outcomes in the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Multimodal Analgesia for Adults Undergoing Surgery of the Spine-A Systematic Review and Meta-Analysis of Three or More Modalities. Licina, A., Silvers, A.[2022]

Multimodal analgesia, which combines various pain management methods, has been shown to effectively reduce opioid use and improve postoperative outcomes in spine surgery, similar to its benefits in lower extremity orthopedic surgeries.

Implementing a standardized multimodal pain management approach in spine surgery could enhance recovery, decrease complications, and improve patient satisfaction, addressing the growing need for effective pain control in a high-volume surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Multimodal Analgesia in Spine Surgery. Kurd, MF., Kreitz, T., Schroeder, G., et al.[2022]

References

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

Paracetamol for multimodal analgesia. [2022]

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

Multimodal analgesia for hip arthroplasty. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Single fixed-dose oral dexketoprofen plus tramadol for acute postoperative pain in adults. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Comparative study of analgesic efficacy and morphine-sparing effect of intramuscular dexketoprofen trometamol with ketoprofen or placebo after major orthopaedic surgery. [2022]

5. Turkey pubmed.ncbi.nlm.nih.gov

The addition of metamizole to morphine and paracetamol improves early postoperative analgesia and patient satisfaction after lumbar disc surgery. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain. [2013]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Systemic multimodality postoperative analgesia in vascular surgery]. [2019]

8. India pubmed.ncbi.nlm.nih.gov

Postoperative outcomes of total knee arthroplasty across varying levels of multimodal pain management protocol adherence. [2022]

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

Perioperative Multimodal Analgesia for Adults Undergoing Surgery of the Spine-A Systematic Review and Meta-Analysis of Three or More Modalities. [2022]

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

The Role of Multimodal Analgesia in Spine Surgery. [2022]