Orthopedic DisorderNCT03862287
Incidence of TNS After Intrathecal Lidocaine v.s Bupivacaine
A study testing Lidocaine and Bupivacaine Hcl 0.5% Inj_#2 in people with Orthopedic Disorder and Leg Injuries, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This study will look into the incidence of Transient neurological symptoms (TNS) after the intrathecal use of lidocaine in comparison to intrathecal Bupivacaine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopedic Disorder, Leg Injuries
- What is being tested?
- Lidocaine and Bupivacaine Hcl 0.5% Inj_#2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3A 1A1
JF Asenjo, MD, 514) 934-1934 ext. 43261, jfasenjog@yahoo.com
JF Asenjo, MD
About this study
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.
Read the detailed description
Ever since the introduction of Spinal anesthesia in 1898 by the German surgeon August Bier, the approach gained wide acceptance by the anesthesia community 1. Since that time, the technique has evolved to accommodate a wide variety of surgical procedures, making it one of the most common regional anesthesia modalities used. The advancement of the anesthesia field has led to the advancement of the technique it self, specially the drugs used in it.
A wide range of local anesthetics has been introduced after the initial successful intrathecal use of cocaine. Starting with amylocaine, and later with the introduction of various local anesthetics such as procaine, 2-chloroprocaine, lidocaine, tetracaine, mepivacaine, prilocaine, bupivacaine, with ropivacaine and levobupivacaine being introduced last. Many of these drugs have fallen out of favour due to various reasons, with Lidocaine, procaine, mepivacaine, ropivacaine and bupivacaine still being used in clinical practice 2.
The choice of the local anesthetic used depends on many factors such as the duration of the operation, the type of surgery and the degree of motor blockade desired. With the advancement of surgery and the increase in day surgical cases, a need for a fast acting, short in duration local anesthetic that allows fast recovery and early discharge has emerged. Of all the local anesthetic drugs available, Lidocaine is one of the drugs that fulfills these needs.
Common complications associated with the use of this technique include headache (5%), backache (11%), hypotension, bradycardia, nausea and vomiting (20%), urinary retention, hypothermia and transient neurological syndrome (TNS). More serious complications include total spinal, infection (meningitis/ encephalitis) and epidural hematoma (<1 in 150,000). On the other hand, complications related to receiving General Anesthesia for the same procedure are similar, with higher chances of nausea and vomiting or airway problems.
TNS is defined as back pain and/or dysesthesia radiating bilaterally to the legs or buttocks after total recovery from spinal anesthesia, manifesting within 24 hours after the surgery and typically lasting less than a week. The etiology of TNS is unknown. Possible contributing factors to the development of TNS include sciatic nerve stretching causing neural ischemia, vasoconstriction of spinal cord arteries, patient positioning, direct needle injury and pooling of local anesthetic in the sacral region. The pathophysiology of TNS is unknown, and there is no specific lab test to diagnose this complication. Treatment of TNS, includes bed rest, administration of nonsteroidal anti inflammatory drugs and sometimes the addition of an opioid is needed 3.
All local anesthetics have been shown to cause TNS, with lidocaine appearing to have the greatest risk. The first reported case of TNS after the single shot administration of 5% hyperbaric lidocaine was published by Schneider and colleagues in 1993 4, which was confirmed later by several other studies 5-9. The reported incidence of TNS after the administration of lidocaine ranges from 10%-40% 10-13. In a more resent study done by F. Salazar et al. the incidence of TNS with lidocaine was reported to be 2.5%, much lower than what was previously described in the literature 14.
Furthermore, in an internal audit done at the MGH looking at all spinal anesthesia cases performed by Dr. Asenjo in the past two years, TNS incidence was found to be 2.7%, far less than what the literature describes, and correlates more with what F. Salazar et al. found in their study. We want to clarify this discrepancy in the incidence of TNS with lidocaine since this is a very inexpensive agent, with a short to intermediate duration of action and readily available world wide. With this purpose we have designed a randomized controlled trial to test the hypothesis that the incidence of TNS after spinal anesthesia with lidocaine is much lower than what was previously described in the literature. This trial will also look at the natural course of the symptoms of TNS.
- Conditions
- Orthopedic Disorder, Leg Injuries
- Being tested
- Lidocaine, Bupivacaine Hcl 0.5% Inj_#2
- Medical subject headings
- Musculoskeletal Diseases, Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
See arm description.
Bupivacaine Hcl 0.5% Inj_#2Drug
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bupivacaine Hcl 0.5% Inj_#2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transient Neurological Symptoms
To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine
Measured: Day 1
Transient Neurological Symptoms
To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine
Measured: Day 3
Secondary outcomes (2)
Transient Neurological Symptoms
To determine the incidence of TNS following the use of intrathecal Bupivacaine
Measured: Day 1 and day 3 postoperative
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
Measured: Day 1 and day 3 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Nov 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JF Asenjo, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862287
- Sponsor's protocol ID
- 2019-4823
- Status last verified
- Mar 2019
- First submitted
- 19 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03862287
- Acronym / sponsor ID
- 2019-4823
- Conditions
- Orthopedic Disorder, Leg Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look into the incidence of Transient neurological symptoms (TNS) after the intrathecal use of lidocaine in comparison to intrathecal Bupivacaine.
Detailed description
Ever since the introduction of Spinal anesthesia in 1898 by the German surgeon August Bier, the approach gained wide acceptance by the anesthesia community 1. Since that time, the technique has evolved to accommodate a wide variety of surgical procedures, making it one of the most common regional anesthesia modalities used. The advancement of the anesthesia field has led to the advancement of the technique it self, specially the drugs used in it.
A wide range of local anesthetics has been introduced after the initial successful intrathecal use of cocaine. Starting with amylocaine, and later with the introduction of various local anesthetics such as procaine, 2-chloroprocaine, lidocaine, tetracaine, mepivacaine, prilocaine, bupivacaine, with ropivacaine and levobupivacaine being introduced last. Many of these drugs have fallen out of favour due to various reasons, with Lidocaine, procaine, mepivacaine, ropivacaine and bupivacaine still being used in clinical practice 2.
The choice of the local anesthetic used depends on many factors such as the duration of the operation, the type of surgery and the degree of motor blockade desired. With the advancement of surgery and the increase in day surgical cases, a need for a fast acting, short in duration local anesthetic that allows fast recovery and early discharge has emerged. Of all the local anesthetic drugs available, Lidocaine is one of the drugs that fulfills these needs.
Common complications associated with the use of this technique include headache (5%), backache (11%), hypotension, bradycardia, nausea and vomiting (20%), urinary retention, hypothermia and transient neurological syndrome (TNS). More serious complications include total spinal, infection (meningitis/ encephalitis) and epidural hematoma (<1 in 150,000). On the other hand, complications related to receiving General Anesthesia for the same procedure are similar, with higher chances of nausea and vomiting or airway problems.
TNS is defined as back pain and/or dysesthesia radiating bilaterally to the legs or buttocks after total recovery from spinal anesthesia, manifesting within 24 hours after the surgery and typically lasting less than a week. The etiology of TNS is unknown. Possible contributing factors to the development of TNS include sciatic nerve stretching causing neural ischemia, vasoconstriction of spinal cord arteries, patient positioning, direct needle injury and pooling of local anesthetic in the sacral region. The pathophysiology of TNS is unknown, and there is no specific lab test to diagnose this complication. Treatment of TNS, includes bed rest, administration of nonsteroidal anti inflammatory drugs and sometimes the addition of an opioid is needed 3.
All local anesthetics have been shown to cause TNS, with lidocaine appearing to have the greatest risk. The first reported case of TNS after the single shot administration of 5% hyperbaric lidocaine was published by Schneider and colleagues in 1993 4, which was confirmed later by several other studies 5-9. The reported incidence of TNS after the administration of lidocaine ranges from 10%-40% 10-13. In a more resent study done by F. Salazar et al. the incidence of TNS with lidocaine was reported to be 2.5%, much lower than what was previously described in the literature 14.
Furthermore, in an internal audit done at the MGH looking at all spinal anesthesia cases performed by Dr. Asenjo in the past two years, TNS incidence was found to be 2.7%, far less than what the literature describes, and correlates more with what F. Salazar et al. found in their study. We want to clarify this discrepancy in the incidence of TNS with lidocaine since this is a very inexpensive agent, with a short to intermediate duration of action and readily available world wide. With this purpose we have designed a randomized controlled trial to test the hypothesis that the incidence of TNS after spinal anesthesia with lidocaine is much lower than what was previously described in the literature. This trial will also look at the natural course of the symptoms of TNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Lidocaine | Active comparator | Drug: LidocainePatients 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. |
| Intrathecal Bupivacaine | Active comparator | Drug: Bupivacaine Hcl 0.5% Inj_#2Patients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineSee arm description. | Drug | Intrathecal Lidocaine |
| Bupivacaine Hcl 0.5% Inj_#2See arm description. | Drug | Intrathecal Bupivacaine |
Primary outcome
Transient Neurological Symptoms
Time frame: Day 1
To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine
Transient Neurological Symptoms
Time frame: Day 3
To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine
2 secondary outcomes
Transient Neurological Symptoms
Time frame: Day 1 and day 3 postoperative
Transient Neurological Symptoms
Time frame: Day 1 and day 3 postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Bupivacaine Hcl 0.5% Inj_#2 in people with Orthopedic Disorder and Leg Injuries, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan F Asenjo (5149341934 ext. 43273, jfasenjog@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transient Neurological Symptoms (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.