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

NCT05824338 | Recruiting Early Phase 1

• 1 other identifier: 2022430
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Keywords

Anesthesia; Spinal; Lumbar surgery; Lower back

Outcome Measures

Primary Outcomes (5)

• Acceptability of study procedures and intervention: eligibility and recruitment

  Number of patients contacted who accepted or declined to participate in the study, with the acceptance rate calculated as the percentage of contacted patients who agreed to participate in the study

  Study duration, until last patient has completed the study (average of 1 year)

• Acceptability of study procedures and intervention: attrition

  Number of patients who complete the study after randomization, with the completion rate calculated as the percentage of randomized patients in whom we were able to collect the Quality of Recovery-15 survey results

  Study duration, until last patient has completed the study (average of 1 year)

• Acceptability of study procedures and intervention: attrition (reasons)

  Reasons why the patient, neurosurgeon and/or anesthesiologist refused to proceed with the patient's pilot study participation

  Study duration, until last patient has completed the study (average of 1 year)

• Determining the success of our randomization procedures: as per protocol

  Number of participants who actually get the intervention assigned to them, calculated as the percentage of randomized patients who receive the anesthetic protocol assigned to them

  Study duration, until last patient has completed the study (average of 1 year)

• Determining the success of our randomization procedures: randomization process

  Similarity of the groups on their baseline characteristics based on the demographic information

  Study duration, until last patient has completed the study (average of 1 year)

Secondary Outcomes (25)

• Preliminary outcome data: height of sensory block after intrathecal administration of study medications

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

• Preliminary outcome data: density of sensory block after intrathecal administration of study medications

  Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)

• Preliminary outcome data: motor block after intrathecal administration of study medications

  Intraoperative and postoperative up to discharge (per patient); study duration after last patient has completed the study (average of 1 year)

• Preliminary outcome data: pain scores

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

• Preliminary outcome data: total dosages of analgesics and sedatives (

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

Other Outcomes (6)

• Assessing appropriateness of data collection intervals

  Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)

• Incidence of complications from spinal anesthesia: anemia

  Intraoperative and postoperative (per patient); study duration after last patient has completed the study (average of 1 year)

• Incidence of intraoperative complications from spinal anesthesia

  Intraoperative (per patient); study duration after last patient has completed the study (average of 1 year)

Study Arms (3)

General anesthesia with endotracheal tube

ACTIVE COMPARATOR

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

Drug: General anesthesia for lumbar surgery

Spinal anesthesia with bupivacaine

ACTIVE COMPARATOR

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

Drug: Spinal anesthesia for lumbar surgery: bupivacaine

Spinal anesthesia with ropivacaine

EXPERIMENTAL

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

Drug: Spinal anesthesia for lumbar surgery: ropivacaine

Interventions

Spinal anesthesia for lumbar surgery: ropivacaine DRUG

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

Also known as: Ropivacaine in the spinal anesthesia for lower lumbar surgery

Spinal anesthesia with ropivacaine

Spinal anesthesia for lumbar surgery: bupivacaine DRUG

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

Also known as: Bupivacaine in the spinal anesthesia for lower lumbar surgery

Spinal anesthesia with bupivacaine

General anesthesia for lumbar surgery DRUG

Patient will be intubated and ventilated under general anesthesia.

Also known as: General Anesthesia with Endotracheal intubation

General anesthesia with endotracheal tube

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraser Health: lead

Study Sites (2)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

NOT YET RECRUITING

Eagle Ridge Hospital

Port Moody, British Columbia, V3H 3W9, Canada

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal; Ropivacaine; Bupivacaine; Anesthesia, General; Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Alan Tung, MD

  Anesthesiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Mozel, MSc.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 21, 2023
• Study Start: August 27, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)