← Back to Search

Local Anesthetic

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

Q: Is this trial accepting participants aged 85 and over?

This trial requires that applicants are aged between 19 and 80, meeting the minimal criteria for enrollment.

Q: What types of people are the ideal candidates for this experiment?

To qualify for this trial, potential participants should have undergone spinal anaesthesia and be aged between 19-80. Only 45 individuals can take part in the study overall.

Q: Are there any openings to join this scientific exploration?

The clinicaltrials.gov database reveals that the recruitment period for this study has ended, as it was originally posted on April 15th 2023 and last modified on April 11th 2023. However, there are 18 other ongoing trials currently accepting new participants.

Q: What goals are the researchers looking to achieve from this experiment?

Primarily, this clinical trial will be assessing the degree of attrition due to Acceptability of Study Procedures and Intervention over its anticipated year-long duration. Secondary objectives are the measurement of sensory block density post intrathecal administration; motor block strength at multiple intervals; and <a href="https://www.withpower.com/clinical-trials/pain">pain</a> levels preoperatively, intraoperatively, on arrival in PACU, upon discharge from PACU to ward or home, and 24 hours after surgery using a numerical rating scale (0 - 10).

Phase < 1

Waitlist Available

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

SASS Trial Summary

This trial will test if spinal anesthesia with ropivacaine is an effective way to do lower spine surgery.

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.Check my eligibility

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.See study design

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.

SASS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Preliminary outcome data: bradycardia

Preliminary outcome data: completion rate

+22 more

Other outcome measures

Assessing appropriateness of data collection intervals

Incidence of complications from spinal anesthesia: anemia

Incidence of intraoperative complications from spinal anesthesia

+3 more

SASS 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

Find a Location

Who is running the clinical trial?

Fraser HealthLead Sponsor

45 Previous Clinical Trials

707,445 Total Patients Enrolled

Alan Tung, MDPrincipal InvestigatorAnesthesiologist

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05824338 — Phase < 1

Spinal Anesthesia Research Study Groups: Spinal anesthesia with bupivacaine, General anesthesia with endotracheal tube, Spinal anesthesia with ropivacaine

Spinal Anesthesia Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT05824338 — Phase < 1

Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05824338 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accepting participants aged 85 and over?

"This trial requires that applicants are aged between 19 and 80, meeting the minimal criteria for enrollment."

Answered by AI

What types of people are the ideal candidates for this experiment?

"To qualify for this trial, potential participants should have undergone spinal anaesthesia and be aged between 19-80. Only 45 individuals can take part in the study overall."

Answered by AI

Are there any openings to join this scientific exploration?

"The clinicaltrials.gov database reveals that the recruitment period for this study has ended, as it was originally posted on April 15th 2023 and last modified on April 11th 2023. However, there are 18 other ongoing trials currently accepting new participants."

Answered by AI

What goals are the researchers looking to achieve from this experiment?

"Primarily, this clinical trial will be assessing the degree of attrition due to Acceptability of Study Procedures and Intervention over its anticipated year-long duration. Secondary objectives are the measurement of sensory block density post intrathecal administration; motor block strength at multiple intervals; and pain levels preoperatively, intraoperatively, on arrival in PACU, upon discharge from PACU to ward or home, and 24 hours after surgery using a numerical rating scale (0 - 10)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Alan Tung 2024. "Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824338.