MedTrace Logo

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

NCT05824338 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-10-08

No results posted yet for this study

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

Interventions

DRUG

Spinal anesthesia for lumbar surgery: ropivacaine

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

DRUG

Spinal anesthesia for lumbar surgery: bupivacaine

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

DRUG

General anesthesia for lumbar surgery

Patient will be intubated and ventilated under general anesthesia.

Sponsors & Collaborators

  • Fraser Health

    lead OTHER

Principal Investigators

  • Alan Tung, MD · Anesthesiologist

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05824338 on ClinicalTrials.gov