Orthopedic Disorder Clinical Trial
Official title:
Is Lidocaine Really Guilty? A Prospective, Randomized, Double Blind Comparison of the Incidence of TNS After Intrathecal Lidocaine Administration vs. Intrathecal Bupivacaine in Patients Undergoing Spinal Anesthesia
This study will look into the incidence of Transient neurological symptoms (TNS) after the intrathecal use of lidocaine in comparison to intrathecal Bupivacaine.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transient Neurological Symptoms | To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine | Day 1 | |
Primary | Transient Neurological Symptoms | To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine | Day 3 | |
Secondary | Transient Neurological Symptoms | To determine the incidence of TNS following the use of intrathecal Bupivacaine | Day 1 and day 3 postoperative | |
Secondary | Transient Neurological Symptoms | To determine the incidence of TNS following the use of either intrathecal Lidocaine and Bupivacaine in patients operated in the lithotomy position | Day 1 and day 3 postoperative |
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