Spinal Anesthesia with Ropivacaine for Lower Back Surgery

(SASS Trial)

Recruiting at 1 trial location

Overseen By Michelle Mozel, MSc.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Fraser Health

Must not be taking: Anticoagulants

Disqualifiers: Allergy to anesthetics, BMI >35, others

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

Compensation: Varies

Number of Visits: 2

Duration: Intraoperative (per patient)

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different anesthesia methods for elective lower back surgery. It compares general anesthesia with two types of spinal anesthesia: bupivacaine and ropivacaine (both local anesthetics). The trial aims to evaluate the effectiveness of these anesthesia methods and gather feedback from patients and medical staff on their use during surgery. It suits individuals planning lower back surgery between the L2 and S1 vertebrae who can choose between spinal or general anesthesia. As an Early Phase 1 trial, this research focuses on understanding how these anesthesia methods function in people, offering participants an opportunity to contribute to foundational knowledge in anesthesia care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), you may not be eligible to participate.

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

Previous studies have shown that ropivacaine takes effect more slowly but is generally well-tolerated for spinal anesthesia. Research comparing different spinal anesthesia drugs found that ropivacaine had a 30% rate of side effects, lower than bupivacaine's 38.3%. This suggests it might cause fewer side effects than bupivacaine, another drug used for similar purposes.

Ropivacaine has been used successfully in surgeries before, indicating reasonable safety. However, since this trial is in its early stages, researchers are still collecting detailed safety information specific to this context. This data helps ensure the drug's safety for use in lower back surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care that typically involves general anesthesia with endotracheal intubation for lower back surgery, researchers are exploring spinal anesthesia with ropivacaine. Ropivacaine is unique because it provides targeted pain relief directly to the spinal area, potentially reducing the need for more invasive intubation methods. Additionally, ropivacaine is known for causing less motor block, which might lead to quicker recovery times and fewer side effects compared to bupivacaine. This makes it an exciting option for patients and doctors hoping for a smoother surgical experience.

What evidence suggests that this trial's treatments could be effective for lower back surgery?

Research has shown that ropivacaine for spinal anesthesia, which participants in this trial may receive, helps patients regain movement faster after surgery compared to bupivacaine, another treatment option in this trial. This enables patients to get up and move around sooner. Studies also indicate that ropivacaine does not weaken muscles, allowing patients to follow surgeons' instructions during surgery. Adding certain pain relievers to low doses of ropivacaine effectively manages pain without affecting movement. Overall, these findings suggest ropivacaine is a promising choice for spinal anesthesia in lower back surgeries. ^{1 2 6 7 8}

Who Is on the Research Team?

Alan Tung, MD

Principal Investigator

Anesthesiologist

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need elective lower back surgery that won't take more than 2 hours. They should be healthy enough for either spinal or general anesthesia and able to understand and answer questions in English. It's not for those with allergies to local anesthetics, BMI over 35, certain heart conditions, infections, blood disorders, previous surgery at the same spine level, or if they can't stay still or move their legs.

Inclusion Criteria

I am scheduled for a specific back surgery from the back side.

I can have surgery with either spinal or general anesthesia.

My upcoming surgery is expected to last no more than 2 hours.

Exclusion Criteria

My upcoming surgery is expected to last over 2 hours.

I am allergic to certain local anesthetics like ropivacaine or bupivacaine.

I have had back surgery before on the same spot that needs surgery now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lower lumbar surgery under one of three anesthesia protocols: general anesthesia with endotracheal tube, spinal anesthesia with bupivacaine, or spinal anesthesia with ropivacaine.

Intraoperative (per patient)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of postoperative complications and quality of recovery.

Postoperative up to 24 hours

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term outcomes and data collection continues until the last patient has completed the study.

Average of 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• General Anesthesia
• Ropivacaine

Trial Overview

The study is testing how feasible it is to use ropivacaine instead of bupivacaine for spinal anesthesia during lower back surgeries. Patients will be randomly assigned to receive general anesthesia with a tube down the throat or spinal anesthesia using either ropivacaine or bupivacaine.

How Is the Trial Designed?

Group I: Spinal anesthesia with ropivacaine Experimental Treatment 1 Intervention

Participants in this group will undergo lower lumbar surgery under spinal anesthesia with ropivacaine 0.5% 10-20 mg with fentanyl 10-15 mcg.

Group II: Spinal anesthesia with bupivacaine Active Control 1 Intervention

Participants in this group will undergo lower lumbar surgery under spinal anesthesia with bupivacaine 0.5% 10-15 mg with fentanyl 10-15 mcg.

Group III: General anesthesia with endotracheal tube Active Control 1 Intervention

Currently the standard at our centre. Participants in this group will undergo lower lumbar surgery with general anesthesia with endotracheal intubation.

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

Fraser Health

Lead Sponsor

Trials

49

Recruited

708,000+

Published Research Related to This Trial

Ropivacaine is approximately half as potent as bupivacaine for spinal anesthesia, meaning that higher doses of ropivacaine are needed to achieve similar effects.

Despite having a similar profile to bupivacaine, ropivacaine is associated with a higher incidence of side effects, such as back pain, and does not provide a clear advantage for outpatient anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric spinal ropivacaine: a comparison to bupivacaine in volunteers. McDonald, SB., Liu, SS., Kopacz, DJ., et al.[2019]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study of 400 patients, spinal anesthesia with levobupivacaine, bupivacaine, and articaine resulted in a significantly lower incidence of transient neurological symptoms (TNS) compared to lidocaine.

The onset of maximum sensory block was slower with articaine than with lidocaine, indicating that while articaine may take longer to take effect, it is associated with fewer TNS cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient neurological symptoms after spinal anesthesia. Gozdemir, M., Muslu, B., Sert, H., et al.[2022]

Spinal anesthesia is a well-established technique known for its high success rate and good safety profile, making it a popular choice for various surgical procedures.

Recent literature suggests that ropivacaine, a new local anesthetic, may enhance spinal anesthesia by providing short-acting effects that support early ambulation and discharge in outpatient care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal use of ropivacaine: a review. Wille, M.[2018]

Adding 1% lidocaine to spinal bupivacaine significantly shortens the duration of anesthesia, allowing for quicker recovery times in patients undergoing procedures like transurethral resection of bladder tumors or prostate surgery.

In a study of 90 patients, those receiving lidocaine with bupivacaine experienced faster regression of sensory and motor blocks compared to those receiving bupivacaine alone, while higher doses of lidocaine (2%) actually prolonged recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The duration of intrathecal bupivacaine mixed with lidocaine. Lee, SJ., Bai, SJ., Lee, JS., et al.[2022]

In a study of 80 patients undergoing lower abdominal surgeries, hyperbaric ropivacaine with 5% dextrose provided a faster onset of sensory block compared to plain ropivacaine, achieving analgesia at T10 in an average of 4 minutes versus 10 minutes (p < 0.001).

Patients receiving hyperbaric ropivacaine experienced a shorter duration of complete motor block (93.06 minutes) compared to those receiving plain ropivacaine (139.89 minutes), allowing for quicker recovery and discharge (p < 0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COMPARATIVE EVALUATION OF PLAIN AND HYPERBARIC ROPIVACAINE IN PATIENTS UNDERGOING LOWER ABDOMINAL SURGERY UNDER SPINAL ANESTHESIA. Dwivedi, P., Kapur, A., Gupta, SK.[2018]

This study established a clear relationship between plasma concentrations of ropivacaine and the level of sensory block during spinal anesthesia, using data from 60 patients and a comprehensive pharmacokinetic-pharmacodynamic model.

Key factors influencing the effectiveness of sensory block included the dose of ropivacaine administered, as well as the patient's age and weight, providing important insights for optimizing anesthesia practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetic-Pharmacodynamic Modeling of Ropivacaine in Spinal Anesthesia. Djerada, Z., Feliu, C., Cazaubon, Y., et al.[2019]

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Comparative Study of Adverse Events Associated with ...

Results: The overall incidence of adverse events was 32.8%, with the highest frequency observed in the bupivacaine group (38.3%), followed by ropivacaine (30.0 ...