Recruiting
Early Phase 1

Ropivacaine

Sponsor:

Fraser Health

Code:

NCT05824338

Conditions

Anesthesia, Spinal

Neurosurgery

Ropivacaine

Bupivacaine

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal anesthesia for lumbar surgery: ropivacaine

Spinal anesthesia for lumbar surgery: bupivacaine

General anesthesia for lumbar surgery

Study Details

Brief summary:

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

Conditions

Anesthesia, Spinal

Neurosurgery

Ropivacaine

Bupivacaine

Study ID

NCT05824338

Start date

Aug 27, 2024

Status verified date

Oct, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: General anesthesia with endotracheal tube

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

active comparator: Spinal anesthesia with bupivacaine

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

experimental: Spinal anesthesia with ropivacaine

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

Interventions

Spinal anesthesia for lumbar surgery: ropivacaine

The anesthesiologist will administer 4 mL of ropivacaine 0.5% plus fentanyl 15 mcg intrathecally

Spinal anesthesia for lumbar surgery: bupivacaine

The anesthesiologist will administer 3 mL of bupivacaine 0.5% plus fentanyl 15 mcg intrathecally.

General anesthesia for lumbar surgery

Patient will be intubated and ventilated under general anesthesia.

Primary outcome measure

  • Acceptability of study procedures and intervention: eligibility and recruitment [ Time Frame: Study duration, until last patient has completed the study (average of 1 year) ]
  • Acceptability of study procedures and intervention: attrition [ Time Frame: Study duration, until last patient has completed the study (average of 1 year) ]
  • Acceptability of study procedures and intervention: attrition (reasons) [ Time Frame: Study duration, until last patient has completed the study (average of 1 year) ]
  • Determining the success of our randomization procedures: as per protocol [ Time Frame: Study duration, until last patient has completed the study (average of 1 year) ]
  • Determining the success of our randomization procedures: randomization process [ Time Frame: Study duration, until last patient has completed the study (average of 1 year) ]

Central Contacts and Locations

Central contacts

Michelle Mozel, MSc.

604-520-4253michelle.mozel@fraserhealth.ca

Locations

Eagle Ridge Hospital

Recruiting

Port Moody, British Columbia, Canada, V3H 3W9

Contacts

Michelle Mozel, MSc.

604-520-4253michelle.mozel@fraserhealth.ca

Principal Investigator:

Alan Tung, MD

More Information

Sponsor

Fraser Health

Last update posted

Oct 8, 2024

Last verified

Oct, 2024

Keywords

  • Anesthesia
  • Spinal
  • Lumbar surgery
  • Lower back

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fraser Health on 2024-10-08.