Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery (SASS)

Fraser Health

Status and phase: Enrolling; Early Phase 1

Conditions: Bupivacaine; Ropivacaine; Neurosurgery; Anesthesia, Spinal

Treatments: Drug: Spinal anesthesia for lumbar surgery: bupivacaine; Drug: Spinal anesthesia for lumbar surgery: ropivacaine; Drug: General anesthesia for lumbar surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05824338

2022430

Details and patient eligibility

About

The goal of this pilot clinical trial is to test the feasibility of conducting a randomized controlled trial that will examine the use of ropivacaine in the spinal anesthesia for patients undergoing elective 1- or 2-level lower spine surgery. This study aims to:

• Determine the rates of eligibility, recruitment, consent, and attrition
• Determine the acceptability among patients, surgeons, anesthesiologists, and nurses of doing spine surgery under spinal anesthesia
• Gather preliminary data on outcomes relevant to a future dose-finding study

Participants will be randomized to one of three treatment groups:

• General anesthesia with endotracheal tube
• Spinal anesthesia with bupivacaine
• Spinal anesthesia with ropivacaine

Enrollment: 45 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients who are equal to or greater than 18 years old
• Undergoing elective one or two-level lumbar surgery via posterior surgical approach in the prone position (between L2-S1)
• Expected surgery duration of no greater than 2 hours
• ASA Physical Status Class 1 to 3
• Patient can have either spinal anesthesia or general anesthesia
• Able to provide consent and understand information in English, and capable of answering questions in English

Exclusion criteria

• Allergy to either ropivacaine, bupivacaine, or local anesthetics
• Contraindications to spinal anesthesia (i.e. coagulopathy or on anticoagulants, severe aortic or mitral valve stenosis, sepsis or bacteremia, thrombocytopenia, high intracranial pressure, infection at the puncture site)
• Surgery is expected to take more than 2 hours
• Emergency surgery
• Previously had back surgery at the level of the spine currently being operated on
• Comorbidities that require the patient to undergo general anesthesia
• Inability to stay still during the surgery
• Inability to move legs preoperatively
• Body Mass Index (BMI) >35
• Multilevel severe spinal stenosis

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

General anesthesia with endotracheal tube

Active Comparator group

Description:

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

Treatment:

Drug: General anesthesia for lumbar surgery

Spinal anesthesia with bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Spinal anesthesia for lumbar surgery: bupivacaine

Spinal anesthesia with ropivacaine

Experimental group

Description:

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

Treatment:

Drug: Spinal anesthesia for lumbar surgery: ropivacaine