Multimodal Pain Package for Post-Spinal Surgery Pain Management

No longer recruiting at 1 trial location

Overseen By Yiliam Rodriguez, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for managing pain after spinal surgeries such as microdiscectomies and spinal decompressions. The goal is to determine if a pre-packaged set of medications, known as the Multimodal Pain Package, is more effective than using separate bottles for each medication. Individuals who have undergone one of these surgeries and require pain relief might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking pain management solution.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using different types of pain relief together, as in the Multimodal Pain Package in this study, is generally safe and well-tolerated. Studies have found that combining various pain relief methods can improve patient comfort after spine surgery. For instance, one study found that adding tramadol, a pain medication, to a multimodal plan reduced pain and helped patients recover faster after surgery.

Overall, evidence suggests that these combined pain management approaches do not cause more side effects than traditional methods. In fact, they might even reduce the need for stronger painkillers, which can have their own risks. While every treatment can have some side effects, research supports the safety of multimodal pain plans for patients similar to those in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Multimodal Pain Package for post-spinal surgery pain management because it simplifies medication delivery while potentially enhancing pain relief. Unlike the standard practice where patients receive individual bottles of medications, this approach combines all necessary drugs into a single, pre-formulated package. This innovation not only aims to enhance patient compliance by making it easier to follow the regimen but also could improve overall pain management by ensuring consistent drug intake. By streamlining the treatment process, this method could lead to more efficient recovery periods and better patient outcomes.

What evidence suggests that this trial's treatments could be effective for post-spinal surgery pain management?

Research shows that combining different pain relief methods, known as multimodal pain management, can be very effective after spine surgery. This trial will compare two approaches: one group will receive a Multi-Modal regimen with medications in a pre-formulated package, while another group will receive Bottled pain formulations with medications in separate bottles. Studies have found that multimodal pain management can reduce pain and decrease the need for opioids, which are strong painkillers. For example, one study found that adding tramadol, a pain relief medication, significantly reduced pain and even shortened the hospital stay for patients undergoing spine surgery. Overall, evidence supports that using multiple medications together effectively controls pain after spinal surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Yiliam Yiliam, MD

Principal Investigator

Professor of Clinical

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Pain Package
• Regular Formulation

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Multimodal Pain Package for:

• Postoperative pain management in spinal surgeries
• Ambulatory pain management

Approved in European Union as Multimodal Analgesia for:

• Postoperative pain management in orthopedic surgeries
• Pain management in ambulatory settings

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+

Published Research Related to This Trial

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]

Multimodal pain management (MMPM) after total knee arthroplasty (TKA) significantly reduces the length of hospital stay (LOS) and the need for high doses of oral morphine equivalents (OMME), indicating its effectiveness in postoperative care.

Patients benefit similarly from a full MMPM regimen that includes acetaminophen, gabapentinoids, and celecoxib, as well as from various combinations of these medications, suggesting flexibility in pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative outcomes of total knee arthroplasty across varying levels of multimodal pain management protocol adherence. Harrison, AE., Kozarek, JDB., Yeh, J., et al.[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]

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]

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6790807/

Multimodal analgesia in pain management after spine surgery This review demonstrates the efficacy in the combined use of opioid-alternative medications such as NSAIDs, gabapentinoids, local anesthetics, acetaminophen,

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875021002321

Multimodal Analgesia in Spine Surgery: An Umbrella Review Multimodal analgesia seems to have an essential role for the optimal management of patients undergoing spine surgery.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31770340/

Multimodal Pain Management and Postoperative ... Multimodal Pain Management and Postoperative Outcomes in Lumbar Spine Fusion Surgery: A Population-based Cohort Study. Spine (Phila Pa 1976).

4. e-neurospine.org e-neurospine.org/m/journal/view.php?number=1704

Narrative Review on Postoperative Pain Management ... In regard to postoperative spine surgery analgesia, the results are mixed. In one study, the authors showed no difference in opioid use in ...

5. jphcs.biomedcentral.com jphcs.biomedcentral.com/articles/10.1186/s40780-024-00381-7

Effectiveness of tramadol-including multimodal analgesia in ... The introduction of tramadol-including MMA can effectively reduce postoperative pain and decrease the LOS for patients undergoing spinal surgery.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05413902

Multi-Modal Anesthesia Protocol in Pain Management of ... This study consisted of a randomized controlled trial designed to evaluate a Multimodal Analgesia (MMA) Protocol on patients undergoing Posterior Spinal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11411861/

Effectiveness of tramadol-including multimodal analgesia ... The introduction of tramadol-including MMA can effectively reduce postoperative pain and decrease the LOS for patients undergoing spinal surgery.