Spinal Anesthesia with Ropivacaine for Lower Back Surgery

(SASS Trial)

Recruiting at 1 trial location

Overseen By Michelle Mozel, MSc.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Fraser Health

Must not be taking: Anticoagulants

Disqualifiers: Allergy to anesthetics, BMI >35, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if ropivacaine can be used to numb the lower spine during surgery. It focuses on patients having lower spine surgery and aims to see if this method is practical and acceptable. Ropivacaine works by blocking pain signals in the nerves of the lower back. Ropivacaine is a local anesthetic that has been shown to provide effective spinal anesthesia with a shorter duration and greater sensory motor dissociation compared to bupivacaine.

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.

What data supports the effectiveness of the drug Ropivacaine for spinal anesthesia in lower back surgery?

Research suggests that Ropivacaine provides effective spinal anesthesia with a shorter duration and better sensory-motor separation compared to Bupivacaine, making it potentially useful for surgeries that require quick recovery, like day care surgeries. ^{1 2 3 4 5}

Is spinal anesthesia with ropivacaine safe for humans?

Spinal anesthesia, including the use of ropivacaine, is generally considered safe with a good safety profile. Studies on similar anesthetics like bupivacaine (Marcaine) show minimal side effects when used correctly, and ropivacaine is being explored for its potential in providing effective anesthesia with a focus on safety. ^{2 3 4 6 7}

How does the drug Ropivacaine differ from other drugs for lower back surgery?

Ropivacaine is unique because it provides spinal anesthesia with a shorter duration and greater sensory motor dissociation compared to bupivacaine, making it particularly useful for outpatient or day care surgeries where quick recovery and discharge are important. ^{3 5 7 8 9}

Research Team

Alan Tung, MD

Principal Investigator

Anesthesiologist

Eligibility Criteria

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.

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Bupivacaine (Local Anesthetic)
• General Anesthesia (Procedure)
• Ropivacaine (Local Anesthetic)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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 (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 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]

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]

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]

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]

References

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

The duration of intrathecal bupivacaine mixed with lidocaine. [2022]

2. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]

4. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

5. Lebanon pubmed.ncbi.nlm.nih.gov

COMPARATIVE EVALUATION OF PLAIN AND HYPERBARIC ROPIVACAINE IN PATIENTS UNDERGOING LOWER ABDOMINAL SURGERY UNDER SPINAL ANESTHESIA. [2018]

6. Canada pubmed.ncbi.nlm.nih.gov

Transient neurological symptoms after spinal anesthesia. [2022]

7. Belgium pubmed.ncbi.nlm.nih.gov

Intrathecal use of ropivacaine: a review. [2018]

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

Hyperbaric spinal ropivacaine: a comparison to bupivacaine in volunteers. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetic-Pharmacodynamic Modeling of Ropivacaine in Spinal Anesthesia. [2019]