Enhanced Recovery Medication Strategies for Lumbar Surgery

(ERAS Trial)

Overseen By Maya Porter, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of California, Davis

Disqualifiers: Trauma, Oncologic, Thromboembolic, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different medication strategies before spine surgery can improve patient recovery and reduce costs. It compares taking all medications orally with some administered intravenously (through an IV) for those undergoing lumbar spine surgery. The trial aims to determine which method aids faster and more comfortable recovery. Candidates for this trial include individuals undergoing lumbar spine surgery for 1 to 3 levels without certain medical complications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in surgical recovery methods.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that both oral and intravenous medications used in Enhanced Recovery After Surgery (ERAS) plans have been well-tolerated in past studies. For the oral group, studies have found that taking medications like acetaminophen, celecoxib, tranexamic acid, and gabapentin before surgery aids recovery and reduces complications. This method has proven safe and effective for quicker recovery.

In the intravenous group, research supports the safety of medications like intravenous acetaminophen and tranexamic acid. Studies have shown that these effectively manage pain after surgery. Participants have generally tolerated these medications well, with no major side effects reported.

Overall, both oral and intravenous methods in ERAS plans have shown promising safety results. They aim to improve recovery and reduce pain after spine surgery, making them a potentially good option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Enhanced Recovery Medication Strategies for Lumbar Surgery because they aim to improve pain management and recovery speed with innovative approaches. Unlike traditional protocols that primarily rely on intravenous pain medications post-surgery, this trial explores the use of oral pre-operative analgesics and a combination of oral and intravenous agents to potentially reduce opioid use and enhance recovery. Group A focuses on all oral medications, including acetaminophen, celecoxib, tranexamic acid, and gabapentin, which may offer a simpler and less invasive option. Meanwhile, Group B incorporates both oral and intravenous agents, with tranexamic acid delivered intravenously at the start of surgery, potentially providing more targeted pain control. These strategies could lead to quicker recovery times and reduced opioid dependency, which is a significant concern in current surgical care.

What evidence suggests that this trial's treatments could be effective for lumbar surgery recovery?

This trial will compare two medication strategies for lumbar surgery. Research has shown that taking pills before surgery, as in Group A: All oral pre-operative analgesics, can manage pain and reduce the need for additional painkillers after spine surgery. This approach may also lead to shorter hospital stays and fewer hospital returns due to pain. Conversely, Group B: Intravenous agents involves treatments given through an IV, which can reduce pain and nausea after spine surgery and lessen the need for more pain medicine afterward. Both methods aim to improve recovery by managing pain effectively and potentially lowering overall healthcare costs. ^{6 7 8 9 10}

Who Is on the Research Team?

Rolando F Roberto, MD

Principal Investigator

Univeristy of California Davis Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for 1 to 3 level lumbar decompression and fusion surgeries. It's not suitable for cancer-related procedures, those who can't move around soon after surgery, spine trauma patients, or anyone with a history of blood clots or heart attacks that make it unsafe to use tranexamic acid.

Inclusion Criteria

I am scheduled for a surgery to relieve pressure in my lower back involving 1 to 3 spinal levels.

Exclusion Criteria

I cannot take tranexamic acid due to a history of blood clots or heart issues.

I have health issues that prevent me from moving around soon after surgery.

I have undergone cancer-related surgeries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Medication Administration

Participants receive either oral or intravenous medications prior to surgery

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo elective orthopaedic spine surgery and immediate postoperative care

0-3 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of postoperative complications and patient-reported outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• All oral administration group
• Enhanced Recovery After Surgery
• Intravenous Infusion group

Trial Overview

The study compares the effects of two preoperative medication methods on recovery after elective spine surgery: one group receives medications through an IV and the other takes them orally. The focus is on how these approaches affect rehabilitation and costs.

How Is the Trial Designed?

Group I: Group A: All oral pre-operative analgesics Active Control 1 Intervention

Group A patients will be administered the following medications in the preoperative holding area: * Acetaminophen 1,000 mg by mouth prior to operation * Celecoxib 200mg by mouth prior to operation * Tranexamic acid 2 grams by mouth prior to operation * Gabapentin 600mg by mouth prior to operation

Group II: Group B: Intravenous agents Active Control 1 Intervention

Group B patients will receive: * Acetaminophen (Ofirmev) 1,000mg intravenous prior to operation * Celecoxib 200mg by mouth prior to operation * Tranexamic acid 2grams intravenous at start of operation * Gabapentin 600 mg by mouth prior to operation

Enhanced Recovery After Surgery is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as ERAS for:

• Colorectal surgery
• Gynecologic surgery
• Orthopedic surgery
• Gastrointestinal surgery

Approved in United States as ERAS for:

• Gynecologic surgery
• Orthopedic surgery
• Gastrointestinal surgery
• Surgical oncology

Approved in Canada as ERAS for:

• General surgery
• Orthopedic surgery
• Gastrointestinal surgery

Approved in China as ERAS for:

• Gastrointestinal surgery
• Orthopedic surgery
• Gynecologic surgery

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8898790/

The Impact of Perioperative Multimodal Pain Management on ...

This study demonstrates that the PMPM protocol is effective in pain control and reducing additional opioid consumption when compared with conventional ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12242756/

Narrative Review on Postoperative Pain Management ...

This narrative review intends on presenting existing evidencebased pain management strategies following spine surgery in both the acute and chronic conditions.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091221006383

Pain Efficacy of perioperative pharmacological and ...

Triple-drug therapy is the most effective pain intervention in adult spine surgery with moderate-to-high certainty of evidence.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1529943019308745

Preoperative multimodal analgesia decreases 24-hour ...

Effective postoperative pain management has been associated with shorter hospital stays, reduced rates of hospital readmissions due to pain, and a decreased ...

5.

jopan.org

jopan.org/article/S1089-9472(24)00095-9/fulltext

Optimizing Postoperative Clinical Outcomes in Spinal ...

Preoperative oral carbohydrate loading is a nonpharmacological intervention that has a positive effect on postoperative clinical outcomes in patients who ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091225006038

Optimising postoperative spine outcomes: an umbrella ...

Background. Enhanced Recovery After Surgery (ERAS) protocols aim to improve recovery, reduce complications, and optimise surgical outcomes.

7.

bmcmusculoskeletdisord.biomedcentral.com

bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-06123-w

Fast-track protocols for patients undergoing spine surgery

The reviewed studies also evidenced that early oral intake after surgery is safe and can accelerate the restoration of bowel function and ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7944908/

Pathway for enhanced recovery after spinal surgery-a ...

Enhanced recovery in spinal surgery (ERSS) has shown promising improvements in clinical and economical outcomes. We have proposed an ERSS pathway based on ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02700451

Post-op Acetaminophen vs NSAID Use on Lumbar Spinal ...

A randomized controlled trial of post-operative acetaminophen versus nonsteroidal anti-inflammatory drug (NSAID) use on lumbar spinal fusion outcomes.

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10156499/

Enhanced Recovery After Surgery (ERAS) protocols for ...

At weill cornell Medical college (NYc, NY, USA) the preoperative care includes oral pre-emptive analgesia containing acetaminophen and gabapentin plus ...