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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of painkillers called NSAIDs (non-steroidal anti-inflammatory drugs) after lumbar spine fusion surgery. Researchers aim to determine if NSAIDs post-surgery increase the likelihood of needing additional surgery due to improper spine healing. The trial includes two groups: one receiving NSAIDs like Ketorolac (also known as Toradol, Acular, or Sprix) and Naproxen, and the other following the usual pain management routine. Individuals with planned lumbar spinal fusion surgery, without kidney disease or a history of stomach issues, might be suitable candidates. As a Phase 4 trial, this research seeks to understand how these FDA-approved and effective treatments can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that ketorolac is generally safe for managing pain after spinal fusion surgery. Patients using ketorolac experienced similar rates of major complications as those who did not. Additionally, ketorolac effectively reduced pain and helped patients leave the hospital sooner.

For naproxen, studies suggest it is safe to use after lumbar spine surgery. Patients taking NSAIDs, such as naproxen, did not face higher risks of surgical complications, including hospital readmission or issues with bone healing. Overall, NSAIDs have proven effective and safe for pain relief during recovery after these surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using NSAIDs like Ketorolac and Naproxen for managing postoperative pain after spinal fusion because they offer a non-opioid alternative, which could reduce the risks associated with opioid use, such as addiction and side effects. Unlike other treatments that primarily rely on opioids for pain relief, NSAIDs work by reducing inflammation, which can be a significant source of pain after surgery. Ketorolac and Naproxen have been shown to effectively manage pain while minimizing the risk of opioid dependency, making them a promising option for enhancing patient recovery and comfort after spinal surgery.

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

Research has shown that both Ketorolac and Naproxen effectively manage pain after back surgery. In this trial, participants in the NSAID group will receive either Ketorolac or Naproxen alongside the standard postoperative regimen. Studies indicate that Ketorolac reduces pain and the need for opioid painkillers, making it a suitable choice for postoperative pain relief. Patients using Ketorolac reported less pain and experienced similar complication rates compared to those who did not use it. Regarding Naproxen, research suggests it can significantly reduce pain shortly after surgery without increasing the risk of healing complications. Overall, these non-steroidal anti-inflammatory drugs (NSAIDs) effectively manage postoperative pain without major side effects. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11536961/

The efficacy and safety of ketorolac for postoperative pain ... The findings suggest that Ketorolac effectively reduces pain and opioid use postoperatively, supporting its role in multimodal analgesia for lumbar spinal ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024000548

The Impact of Ketorolac Utilization on Outcomes for ... Overall, patients had similar rates of major complications (3.7% vs. 5.4%) and minor complications (42.1% vs. 51.7%) between groups after lumbar surgery.

3. researchgate.net researchgate.net/publication/385561383_The_efficacy_and_safety_of_ketorolac_for_postoperative_pain_management_in_lumbar_spine_surgery_a_meta-analysis_of_randomized_controlled_trials

(PDF) The efficacy and safety of ketorolac for postoperative ... The findings suggest that Ketorolac effectively reduces pain and opioid use postoperatively, supporting its role in multimodal analgesia for lumbar spinal ...

4. journals.lww.com journals.lww.com/painrpts/fulltext/2022/06000/postoperative_pain_treatment_after_spinal_fusion.8.aspx

Postoperative pain treatment after spinal fusion surgery Concerning secondary outcomes, significant reductions in pain scores were detected after 6 hours at rest (NSAID [P < 0.0001] and intrathecal morphine [P < ...

5. ircmj.com ircmj.com/article_224575_bdb2c936f58ed4f751297007a4408a7f.pdf

Comparing Ketorolac and Ketamine for Postoperative Pain ... →Meaning Ketorolac or ketamine with morphine improves pain control after lumbar fusion, with ketorolac being most effective. Comparing Ketorolac ...

6. journals.lww.com journals.lww.com/spinejournal/abstract/9900/postoperative_ketorolac_administration_and.1100.aspx

Postoperative Ketorolac Administration and ... These results suggest ketorolac could be a safe option for managing pain after spinal fusion surgery. Text is machine generated and may ...

7. rheumatologyadvisor.com rheumatologyadvisor.com/news/ketorolac-is-safe-effective-for-pain-management-following-lumbar-spine-surgery/

Ketorolac Is Safe, Effective for Pain Management Following ... At 0 to 6 hours post-surgery, ketorolac significantly reduced pain scores by a mean difference (MD) of -1.42 (95% CI, -2.03 to -0.80; P <.0001) ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39501393/

The efficacy and safety of ketorolac for postoperative pain ... Ketorolac administration also significantly reduced the LOS compared to controls (MD = - 0.45 days; 95% CI = - 0.74 to - 0.16; P = 0.0001), ...