Spinal AnesthesiaPhase 3NCT00332735
Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery
A Phase 3 study testing spinal administration of articaine and spinal administration of bupivacaine in people with Spinal Anesthesia, run by Reinier de Graaf Groep at 1 site in Netherlands.
Trial summary
The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be compared. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- spinal administration of articaine and spinal administration of bupivacaine
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2006to Jan 2007
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Patients planned for an outpatient lower limb surgery
- Procedure under spinal anesthesia
- Informed consent
Who cannot join
- Contra-indications spinal anesthesia
- History of allergic reactions on amide-type local anesthetics
- Length < 1.60 m or > 1.90 m
- BMI < 18.5 kg/m2 or > 35 kg/m2
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial
The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be compared.
Read the detailed description
The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery.
Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery, e.g. knee arthroscopy, foot and varices surgery. Patients will recover faster and less complications will be expected.
Articaine is said to act faster and shorter than a low dose of bupivacaine. There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine.
Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial.
Endpoints are:
- onset of sensory and motor block
- maximum spread of sensory level
- recovery from sensory and motor block
- time to micturition
- complications
- Conditions
- Spinal Anesthesia
- Being tested
- spinal administration of articaine, spinal administration of bupivacaine
- Keywords
- spinal, anesthesia, articaine, bupivacaine, outpatient, surgery, limbs
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 bupivacaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery time from motor blockade
Secondary outcomes (6)
onset of sensory and motor blockade
maximum spread of sensory blockade (30 min after spinal injection of anesthetic)
spread of sensory blockade after 1,5 hour
recovery time from sensory blockade
time to micturation
complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMay 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Reinier de Graaf Groep
- Sponsor type
- University, hospital or other
- Investigators
- Tessa Dijkstra, drs, Principal investigator, Reinier de Graaf Groep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332735
- Sponsor's protocol ID
- METC-nr 06-010
- Status last verified
- Apr 2007
- First submitted
- 31 May 2006
- Last updated
- 19 Apr 2007
- Results posted
- 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 15966499Alston RP. Spinal anaesthesia with 0.5% bupivacaine 3 ml: comparison of plain and hyperbaric solutions administered to seated patients. Br J Anaesth. 1988 Oct;61(4):385-9. doi: 10.1093/bja/61.4.385.
PubMed 3190969Axelsson KH, Widman GB, Sundberg AE, Hallgren S. A double-blind study of motor blockade in the lower limbs. Studies during spinal anaesthesia with hyperbaric and glucose-free 0.5% bupivacaine. Br J Anaesth. 1985 Oct;57(10):960-70. doi: 10.1093/bja/57.10.960.
PubMed 4041323Kaukinen 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 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00332735
- Acronym / sponsor ID
- METC-nr 06-010
- Conditions
- Spinal Anesthesia
- Keywords
- spinal, anesthesia, articaine, bupivacaine, outpatient, surgery, limbs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Reinier de Graaf GroepUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Jun 2006 (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 the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be compared.
Detailed description
The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery.
Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery, e.g. knee arthroscopy, foot and varices surgery. Patients will recover faster and less complications will be expected.
Articaine is said to act faster and shorter than a low dose of bupivacaine. There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine.
Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial.
Endpoints are:
- onset of sensory and motor block
- maximum spread of sensory level
- recovery from sensory and motor block
- time to micturition
- complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 70 years
- Patients planned for an outpatient lower limb surgery
- Procedure under spinal anesthesia
- Informed consent
Key exclusion criteria (5 listed)
- Contra-indications spinal anesthesia
- History of allergic reactions on amide-type local anesthetics
- Length < 1.60 m or > 1.90 m
- BMI < 18.5 kg/m2 or > 35 kg/m2
- 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 | – |
| spinal administration of bupivacaine | Drug | – |
Primary outcome
recovery time from motor blockade
6 secondary outcomes
onset of sensory and motor blockade
maximum spread of sensory blockade (30 min after spinal injection of anesthetic)
spread of sensory blockade after 1,5 hour
recovery time from sensory blockade
time to micturation
complications
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 Apr 2007.
- 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.
- Background: PubMed 3190969Alston RP. Spinal anaesthesia with 0.5% bupivacaine 3 ml: comparison of plain and hyperbaric solutions administered to seated patients. Br J Anaesth. 1988 Oct;61(4):385-9. doi: 10.1093/bja/61.4.385.
- Background: PubMed 4041323Axelsson KH, Widman GB, Sundberg AE, Hallgren S. A double-blind study of motor blockade in the lower limbs. Studies during spinal anaesthesia with hyperbaric and glucose-free 0.5% bupivacaine. Br J Anaesth. 1985 Oct;57(10):960-70. doi: 10.1093/bja/57.10.960.
- Background: 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.
Tessa Dijkstra, drs principal investigator
Reinier de Graaf Groep
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 bupivacaine in people with Spinal Anesthesia, run by Reinier de Graaf Groep 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 4 inclusion and 5 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 Apr 2007. 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?
recovery time from motor blockade. 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 NCT00332735, which also lists 4 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 Apr 2007.