Intrathecal Morphine + Clonidine for Lumbar Fusion Surgery

JR
PM
Overseen ByParker Merrill, MD
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of pain control for individuals undergoing spinal fusion surgery. Participants will receive either the standard pain treatment with intrathecal morphine (a pain medication delivered into the spinal fluid) or an experimental combination of intrathecal morphine and clonidine, a drug that might enhance pain relief. The researchers aim to determine if adding clonidine can improve pain control after surgery. Eligible participants must speak English, be scheduled for lumbar spine fusion surgery, and plan to stay in the hospital for at least 24 hours post-procedure. While joining the trial might not directly benefit participants, it could lead to improved pain management options for future patients. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking pain management solution.

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

Research has shown that combining intrathecal morphine and clonidine can help manage pain after spine surgeries. In one study, patients who received clonidine with morphine reported good pain relief. However, this combination can cause side effects, such as dose-dependent slowed breathing.

Patients using intrathecal morphine have experienced effective pain relief but may also face side effects like nausea and itching. Adding clonidine to morphine has reduced the need for extra pain medication, suggesting its effectiveness.

Overall, while both treatments are effective, side effects can vary among individuals. Prospective trial participants should discuss these potential risks with their doctor.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for pain management in lumbar fusion surgery, which typically involves intrathecal morphine alone, this new approach combines intrathecal morphine with intrathecal clonidine. Researchers are excited about this combination because clonidine is known to enhance pain relief by acting on different receptors in the spinal cord, potentially leading to better pain control with fewer side effects. This dual-action method could mean more effective pain management and a smoother recovery process for patients undergoing lumbar fusion surgery.

What evidence suggests that this trial's treatments could be effective for pain control in lumbar fusion surgery?

Research has shown that combining intrathecal morphine with clonidine can better manage pain for patients undergoing lumbar fusion surgery. In this trial, some participants will receive intrathecal morphine alone, the current standard of care, while others will receive the experimental treatment, which adds intrathecal clonidine to the standard morphine regimen. Studies have found that clonidine, when used with morphine, can enhance pain relief and may allow for lower morphine doses. This combination might also reduce the risk of side effects often associated with higher morphine doses. Clonidine works by affecting specific parts of the nervous system that control pain. Early results suggest this method can provide better pain management than morphine alone.

Who Is on the Research Team?

PM

Parker Merrill, MD

Principal Investigator

MaineHealth

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-70 who are scheduled to have a 1-2 level lumbar spine fusion surgery. People outside this age range or not having this specific surgery cannot participate.

Inclusion Criteria

ASA I-III
English speaking
I am expected to stay in the hospital for at least 24 hours after surgery.
See 2 more

Exclusion Criteria

Substance use disorder
Pregnant patients
Baseline systolic blood pressure less than 100
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intrathecal morphine or intrathecal morphine combined with clonidine during lumbar fusion surgery

During surgery

Post-operative Monitoring

Participants' pain levels and opioid consumption are monitored for 72 hours post-operation

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Intrathecal Clonidine
  • Intrathecal Morphine

Trial Overview

The study compares two pain control methods during spinal fusion: one group receives morphine injected into the spine, while the other gets both morphine and clonidine in the same way. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intrathecal Morphine + Intrathecal ClonidineExperimental Treatment1 Intervention
Group II: Intrathecal MorphineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MaineHealth

Lead Sponsor

Trials
76
Recruited
43,800+

Citations

Effectiveness and Safety of Intrathecal Morphine for ...

In this systematic review and meta-analysis, we compare clinical outcomes following ITM use to standard pain management for pediatric patients.

Intrathecal Morphine Recommended for Analgesia After ...

Intrathecal Morphine Recommended for Analgesia After Lumbar Spine Surgery. DGDispatch. By: Ref: Published: 06/19/ ...

Long-Term Outcomes During Treatment of Chronic Pain ...

After initiation of intrathecal clonidine, one patient reported good relief with clonidine/morphine until his death 5 months later. In this population, ...

Analgesic Efficacy of Intrathecal Fentanyl-Morphine ...

The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic ...

Application Of The 2022 CDC Guidelines ...

S: Daily MME consumption after lumbar fusion was an independent predictor of post-discharge MME consumption for up to a year amongst opioid ...