Recruiting

Lidocaine vs. Bupivacaine

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT03862287

Conditions

Orthopedic Disorder

Leg Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lidocaine

Bupivacaine Hcl 0.5% Inj_#2

Study Details

Brief summary:

This study will look into the incidence of Transient neurological symptoms (TNS) after the intrathecal use of lidocaine in comparison to intrathecal Bupivacaine.

Conditions

Orthopedic Disorder

Leg Injuries

Study ID

NCT03862287

Start date

Nov 1, 2018

Status verified date

Mar, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ASA I-III male and female patients aged between 18 to 80 years old, who will receive spinal anesthesia for surgeries lasting less than one hour.

Exclusion Criteria:

  • Patients younger than 18 years old.
  • ASA physical status >3.
  • Immunosuppression or high risk of infection.
  • Contraindications to receiving spinal anesthesia (e.g. coagulation impairment).
  • Patients with psychosis
  • Patients with preexisting back pain.
  • Patients with cognitive impairment
  • Allergies to local anesthetics, analgesics or any medication used in the study.
  • Patients with chronic regular opioid usage
  • Presence of preexisting neurological symptoms.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intrathecal Lidocaine

Patients will receive spinal anesthesia in the sitting position under strict sterile conditions in the operating room. Using a median or paramedian approach, the spinal needle will be inserted into the L2-3 or L3-4 interspace to reach the subarachnoid space. After confirming the space by free flow of CSF, 60 mg of isobaric preservative-free Lidocaine 2% will be injected. Sedation using propofol infusion (50-100 mcg/kg/min) and fentanyl (0.5-1 mcg/kg) will be given throughout the procedure as required.

active comparator: Intrathecal Bupivacaine

Patients will receive spinal anesthesia in the sitting position under strict sterile conditions in the operating room. Using a median/paramedian approach, the spinal needle will be inserted into the L2-3 or L3-4 interspace to reach the subarachnoid space. After confirming the space by free flow of CSF, 6 mg of 0.5% isobaric bupivacaine will be injected. Sedation using propofol infusion (50-100 mcg/kg/min) and fentanyl (0.5-1 mcg/kg) will be given throughout the procedure as required.

Interventions

Lidocaine

See arm description.

Bupivacaine Hcl 0.5% Inj #2

See arm description.

Primary outcome measure

  • Transient Neurological Symptoms [ Time Frame: Day 1 ]
  • Transient Neurological Symptoms [ Time Frame: Day 3 ]

Central Contacts and Locations

Central contacts

Juan F Asenjo

5149341934jfasenjog@yahoo.com

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

JF Asenjo, MD

514) 934-1934jfasenjog@yahoo.com

Principal Investigator:

JF Asenjo, MD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Mar 5, 2019

Last verified

Mar, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2019-03-05.