Spinal AnesthesiaPhase 3NCT00247741
Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.
A Phase 3 study testing spinal administration of articaine and spinal administration of lidocaine in people with Spinal Anesthesia, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare two short-acting local anesthetics, articaine and lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and motor block, recovery time until discharge and complications will be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- spinal administration of articaine and spinal administration of lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2005to May 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- ASA I-III
- Patients planned for a short surgical procedure on lower extremities or lower abdomen.
- Procedure in day-case setting
- Procedure under spinal anesthesia
- Informed consent
Who cannot join
- Contra-indications spinal anesthesia
- History of allergic reactions on amide-type local anesthetics
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.
The purpose of this study is to compare two short-acting local anesthetics, articaine and lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and motor block, recovery time until discharge and complications will be studied.
Read the detailed description
The ideal spinal anesthesia in day-case surgery is characterized by a short onset of sensory and motor blockade, and a rapid recovery after the operation. Short-acting local-anesthetics are used frequently in this setting.
Lidocaine is one of the agents that is used most frequently. It has been associated with an increased incidence of Transient Neurological Symptoms (TNS). Articaine is another agent that is being used more often and is said to act faster and shorter than lidocaine.
We will compare spinal anesthesia with lidocaine and articaine in a randomized double-blind clinical trial. Endpoint are:
- onset of sensory and motor block
- recovery from sensory and motor block
- time to micturition
- patient satisfaction
- complications
- Conditions
- Spinal Anesthesia
- Being tested
- spinal administration of articaine, spinal administration of lidocaine
- Keywords
- spinal anesthesia, lidocaine, articaine, intrathecal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal administration of articaineDrug
spinal administration of lidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Active comparator | Not described Receives: Drug: spinal administration of lidocaine |
| articaine | Experimental | Not described Receives: Drug: spinal administration of articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time (sec) of sensory and motor blockade (after administration of drug)
Recovery time (min) from sensory and motor blockade
Spread of sensory blockade (30 min after administration of drug, dermatomal level)
Secondary outcomes (3)
Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
Complications
Patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startNov 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Leon Timmerman, MD, Principal investigator, St Antonius Hospital, dept. of anesthesiologyEmile MJ Andriessen, MD, Study chair, St Antonius Hospital, dept of anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247741
- Sponsor's protocol ID
- Articaine
- Status last verified
- Oct 2005
- First submitted
- 1 Nov 2005
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.
PubMed 15966499Kaukinen S, Eerola R, Eerola M, Kaukinen L. A comparison of carticaine and lidocaine in spinal anaesthesia. Ann Clin Res. 1978 Aug;10(4):191-4.
PubMed 360957
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT00247741
- Acronym / sponsor ID
- Articaine
- Conditions
- Spinal Anesthesia
- Keywords
- spinal anesthesia, lidocaine, articaine, intrathecal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- May 2006
- First posted
- 2 Nov 2005 (estimated)
- 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.
The purpose of this study is to compare two short-acting local anesthetics, articaine and lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and motor block, recovery time until discharge and complications will be studied.
Detailed description
The ideal spinal anesthesia in day-case surgery is characterized by a short onset of sensory and motor blockade, and a rapid recovery after the operation. Short-acting local-anesthetics are used frequently in this setting.
Lidocaine is one of the agents that is used most frequently. It has been associated with an increased incidence of Transient Neurological Symptoms (TNS). Articaine is another agent that is being used more often and is said to act faster and shorter than lidocaine.
We will compare spinal anesthesia with lidocaine and articaine in a randomized double-blind clinical trial. Endpoint are:
- onset of sensory and motor block
- recovery from sensory and motor block
- time to micturition
- patient satisfaction
- complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Active comparator | Drug: spinal administration of lidocaine |
| articaine | Experimental | Drug: spinal administration of articaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- ASA I-III
- Patients planned for a short surgical procedure on lower extremities or lower abdomen.
- Procedure in day-case setting
- Procedure under spinal anesthesia
Key exclusion criteria (3 listed)
- Contra-indications spinal anesthesia
- History of allergic reactions on amide-type local anesthetics
- Pregnancy
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 |
|---|---|---|
| spinal administration of articaine | Drug | articaine |
| spinal administration of lidocaine | Drug | lidocaine |
Primary outcome
Onset time (sec) of sensory and motor blockade (after administration of drug)
Recovery time (min) from sensory and motor blockade
Spread of sensory blockade (30 min after administration of drug, dermatomal level)
3 secondary outcomes
Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
Complications
Patient satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Background: PubMed 15966499Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.
- Results publication: PubMed 360957Kaukinen S, Eerola R, Eerola M, Kaukinen L. A comparison of carticaine and lidocaine in spinal anaesthesia. Ann Clin Res. 1978 Aug;10(4):191-4.
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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.
Leon Timmerman, MD principal investigator
St Antonius Hospital, dept. of anesthesiology
Emile MJ Andriessen, MD study chair
St Antonius Hospital, dept of anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing spinal administration of articaine and spinal administration of lidocaine in people with Spinal Anesthesia, run by St. Antonius Hospital at 1 site in Netherlands.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 19 Dec 2013. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset time (sec) of sensory and motor blockade (after administration of drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247741, which also lists 2 linked publications.
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 19 Dec 2013.