Pain Medications for Postoperative Pain After Spinal Fusion

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rothman Institute Orthopaedics

Must not be taking: NSAIDs

Disqualifiers: Chronic kidney disease, Gastrointestinal bleed, 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: Immediate postoperative period

428 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), you might need to discuss this with the trial team, as the study involves these medications.

What data supports the effectiveness of the drug Ketorolac for postoperative pain after spinal fusion?

Research shows that Ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), can decrease postoperative pain and reduce the need for opioids in spinal surgeries, which is beneficial given the opioid addiction crisis. ^{1 2 3 4 5}

Is ketorolac safe for managing postoperative pain?

Ketorolac is generally considered safe for managing postoperative pain, but it can have side effects like increased bleeding and potential kidney issues, especially in people with existing risk factors. It has been shown to reduce the need for opioids, but more research is needed to fully understand its safety profile. ^{5 6 7 8 9}

How is the drug combination of Ketorolac and Naproxen unique for managing postoperative pain after spinal fusion?

The combination of Ketorolac and Naproxen for postoperative pain after spinal fusion is unique because Ketorolac, despite concerns about affecting bone healing, may not impact fusion rates when used short-term and in low doses, offering an alternative to high-dose opioids. This approach aligns with the concept of balanced analgesia, which uses multiple drugs to enhance pain relief and minimize side effects. ^{1 10 11 12 13}

Eligibility Criteria

This trial is for patients who have had elective lumbar spinal fusion surgery and are managing postoperative pain. Participants should not have conditions that prevent the use of NSAIDs, such as kidney failure or a history of stomach ulcers.

Inclusion Criteria

I am able to participate in a clinical trial.

English speaking

I am over 18 and scheduled for a lumbar spinal fusion surgery.

Exclusion Criteria

I have a connective tissue disease.

Preoperative thrombocytopenia (platelets <100,000)

My kidney function is reduced with a creatinine level of 1.4 or higher.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NSAIDs or standard postoperative regimen following lumbar spine fusion surgery

Immediate postoperative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on fusion success and need for revision surgery

2 years

Treatment Details

Interventions

• Ketorolac
• Naproxen

Trial Overview The study is testing if using NSAIDs like Ketorolac, Naproxen, and Metaxalone after spine surgery affects the healing process over two years compared to not using these drugs. It's a randomized controlled trial.

Participant Groups

Group I: Group 1: NSAID Group Active Control 4 Interventions

Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery

Group II: Group 2: Control Group Active Control 2 Interventions

Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery

Ketorolac is already approved in United States, European Union, Switzerland for the following indications:

Approved in United States as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea
• Idiopathic pericarditis
• Ocular itching

Approved in European Union as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea

Approved in United States as Acular for:

• Ocular itching
• Inflammation after eye surgery

Approved in United States as Sprix for:

• Moderate to severe pain

Approved in Switzerland as Ketorolac for:

• Moderate to severe pain
• Postoperative pain

Who Is Running the Clinical Trial?

Rothman Institute Orthopaedics

Lead Sponsor

Trials

127

Recruited

22,600+

Findings from Research

In a study of 225 patients undergoing thoracolumbar spinal fusions, a single dose of intraoperative IM ketorolac did not significantly reduce overall opioid use or length of hospital stay, indicating it may not be effective in minimizing opioid requirements post-surgery.

However, ketorolac showed potential benefits in early pain control on the first postoperative day, suggesting it could be a useful component of a multimodal pain management strategy in spine surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Intraoperative Local Ketorolac on Opioid Use in the Management of Postoperative Pain in Thoracolumbar Spinal Fusions: A Retrospective Cohort Study. Lytle, E., Claus, C., Yoon, E., et al.[2022]

A multimodal approach to pain control after orthopedic surgery, which includes nonopioid agents like intravenous acetaminophen and intranasal ketorolac, offers better pain relief with fewer side effects compared to using opioids alone.

This review highlights the importance of incorporating newer nonopioid medications alongside established treatments like ketamine and gabapentinoids to enhance analgesia, especially in the context of the ongoing opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on Multimodal Analgesia for Orthopedic Surgery. Pitchon, DN., Dayan, AC., Schwenk, ES., et al.[2018]

In a study involving 252 patients with postoperative pain from hip or knee replacement surgery, dexketoprofen trometamol and racemic ketoprofen demonstrated equivalent analgesic efficacy, indicating both are effective options for pain management.

Dexketoprofen trometamol showed a trend towards better tolerability, with fewer treatment-related adverse events (16%) compared to ketoprofen (21.3%), suggesting it may be a safer choice for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and safety of intravenously administered dexketoprofen trometamol and ketoprofen in the management of pain after orthopaedic surgery: A multicentre, double-blind, randomised, parallel-group clinical trial. Zippel, H., Wagenitz, A.[2022]

In a study of 208 children who underwent scoliosis surgery, the use of ketorolac did not lead to a significant increase in postoperative complications such as transfusion or reoperation rates.

The analysis showed no significant differences in various clinical factors between children who received ketorolac and those who did not, suggesting that ketorolac can be safely used in this surgical context without raising complication risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of ketorolac tromethamine in children undergoing scoliosis surgery. an analysis of complications. Vitale, MG., Choe, JC., Hwang, MW., et al.[2019]

Ketorolac tromethamine is an effective nonsteroidal anti-inflammatory drug (NSAID) for managing moderate to severe postoperative pain, reducing the need for opioid analgesics, which can help minimize opioid-related side effects.

Administered intramuscularly, ketorolac reaches peak plasma levels in about 45 to 50 minutes and has a low incidence of side effects, making it a promising option for both inpatient and outpatient pain management, although further research is needed to fully understand its role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac: a new parenteral nonsteroidal anti-inflammatory drug for postoperative pain management. Lassen, K., Epstein-Stiles, M., Olsson, GL.[2013]

In a study of 127 patients undergoing major surgery, intranasal ketorolac at a dose of 31.5 mg significantly reduced the need for supplemental morphine compared to placebo and the lower 10 mg dose, indicating its efficacy in managing postoperative pain.

The 31.5 mg dose of ketorolac also resulted in lower rates of pyrexia and tachycardia compared to placebo, suggesting a better safety profile while effectively controlling pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Moodie, JE., Brown, CR., Bisley, EJ., et al.[2013]

Ketorolac tromethamine is an effective nonsteroidal anti-inflammatory drug (NSAID) used for pain management, particularly in emergency and postoperative settings, but it can lead to acute renal failure and hyperkalemia in susceptible individuals.

In three reported cases, patients with risk factors for kidney issues developed these complications after receiving moderate doses of ketorolac, but both conditions were reversible upon stopping the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac-induced acute renal failure and hyperkalemia: report of three cases. Haragsim, L., Dalal, R., Bagga, H., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Parecoxib Reduced Postsurgical Pain and Facilitated Movement More Than Patient Controlled Analgesia. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The Impact of Intraoperative Local Ketorolac on Opioid Use in the Management of Postoperative Pain in Thoracolumbar Spinal Fusions: A Retrospective Cohort Study. [2022]

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

Updates on Multimodal Analgesia for Orthopedic Surgery. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and safety of intravenously administered dexketoprofen trometamol and ketoprofen in the management of pain after orthopaedic surgery: A multicentre, double-blind, randomised, parallel-group clinical trial. [2022]

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

Use of ketorolac tromethamine in children undergoing scoliosis surgery. an analysis of complications. [2019]

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

Ketorolac: a new parenteral nonsteroidal anti-inflammatory drug for postoperative pain management. [2013]

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

The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. [2013]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Ketorolac. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. [2022]

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

Ketorolac-induced acute renal failure and hyperkalemia: report of three cases. [2019]

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

The effect of ketorolac on posterior minimally invasive transforaminal lumbar interbody fusion: an interim analysis from a randomized, double-blinded, placebo-controlled trial. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Loxoprofen sodium and celecoxib for postoperative pain in patients after spinal surgery: a randomized comparative study. [2022]

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

The analgesic efficacy of celecoxib, pregabalin, and their combination for spinal fusion surgery. [2015]

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

Postoperative analgesia with i.v. propacetamol and ketoprofen combination after disc surgery. [2013]