What side effects are associated with this type of intervention?

Spinal anesthesia, including treatments with local anesthetics like ropivacaine, commonly results in side effects such as hypotension, headache, back pain, and transient neurological symptoms. Specific to ropivacaine, patients may experience nausea, dizziness, and in rare instances, systemic toxicity that can affect the cardiovascular and central nervous systems. These side effects are generally manageable but require careful monitoring during and after the procedure.

What prior FDA approvals exist?

Local anesthetics such as ropivacaine and bupivacaine are commonly used for spinal anesthesia to block nerve signal transmission. These drugs have been studied and utilized for their efficacy in providing regional anesthesia during surgeries. Ropivacaine, in particular, is noted for its favorable safety profile and reduced potential for motor blockade compared to other local anesthetics. While specific FDA approval details for spinal anesthesia applications are not provided, these drugs are widely accepted and used in clinical practice for this purpose.

What other types of research exist?

Promising novel alternatives to Ropivacaine for spinal anesthesia include Bupivacaine and Lidocaine. Bupivacaine is already widely used and has a well-established safety profile. Lidocaine, particularly in intravenous form, has shown efficacy in reducing postoperative pain and opioid consumption. Emerging therapies such as the use of continuous intravenous lidocaine infusion are also being explored for their potential benefits in spinal anesthesia.

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Local Anesthetic

Spinal Anesthesia with Ropivacaine for Lower Back Surgery (SASS Trial)

Phase < 1

Recruiting

Led By Alan Tung, MD

Research Sponsored by Fraser Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from ropivacaine and bupivacaine include low blood pressure, numbness beyond the targeted area, difficulty urinating, headaches after the procedure (spinal headache), nausea and vomiting. General anesthesia may cause sore throat due to the tube insertion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative up to 24 hours (per patient); study duration after last patient has completed the study (average of 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of study procedures and intervention: attrition

Acceptability of study procedures and intervention: attrition (reasons)

Acceptability of study procedures and intervention: eligibility and recruitment

+2 more

Secondary study objectives

Preliminary outcome data: anesthesiologist's workload when conducting neurosurgery under spinal anesthesia

Preliminary outcome data: bradycardia

Preliminary outcome data: completion rate

+22 more

Other study objectives

Assessing appropriateness of data collection intervals

Incidence of complications from spinal anesthesia: anemia

Incidence of intraoperative complications from spinal anesthesia

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Spinal anesthesia with ropivacaineExperimental Treatment1 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 bupivacaineActive Control1 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 tubeActive Control1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Local anesthetics such as ropivacaine and bupivacaine are commonly used in spinal anesthesia. They work by blocking sodium channels on nerve cells, which prevents the initiation and transmission of nerve signals. This blockade results in a loss of sensation and muscle control in the targeted area, providing effective pain relief during surgical procedures. The choice of anesthetic and its properties, such as duration of action and potential side effects, are critical for tailoring anesthesia to individual patient needs, ensuring both efficacy and safety.

The Options for Neuraxial Drug Administration.