NCT03862287

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

February 19, 2019

Last Update Submit

March 1, 2019

Conditions

Orthopedic DisorderLeg Injuries

Outcome Measures

Primary Outcomes (2)

  • Transient Neurological Symptoms

    To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine

    Day 1

  • Transient Neurological Symptoms

    To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine

    Day 3

Secondary Outcomes (2)

  • Transient Neurological Symptoms

    Day 1 and day 3 postoperative

  • Transient Neurological Symptoms

    Day 1 and day 3 postoperative

Study Arms (2)

Intrathecal Lidocaine

ACTIVE COMPARATOR

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.

Drug: Lidocaine

Intrathecal Bupivacaine

ACTIVE COMPARATOR

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.

Drug: Bupivacaine Hcl 0.5% Inj_#2

Interventions

LidocaineDRUG

See arm description.

Intrathecal Lidocaine
Bupivacaine Hcl 0.5% Inj_#2DRUG

See arm description.

Intrathecal Bupivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

MeSH Terms

Conditions

Musculoskeletal DiseasesLeg Injuries

Interventions

LidocaineBupivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Juan F Asenjo

CONTACT

5149341934jfasenjog@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia

Study Record Dates

First Submitted

February 19, 2019

First Posted

March 5, 2019

Study Start

November 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

CA(1)