Spinal AnesthesiaPhase 4NCT01245868
Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine
A Phase 4 study testing Lidocaine and bupivacaine in people with Spinal Anesthesia, run by Frederikssunds Hospital, Denmark at 2 sites in Denmark.
Trial summary
The purpose of the study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Lidocaine and bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2009to Dec 2010
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient want spinal anaesthesia
- No contradictions against spinal anaesthesia
- Healthy people (ASA-score 1 or 2)
- Body mass index < 35 and between 155 and 190 cm
Who cannot join
- Known allergic reactions to planned drugs
- Neurologic disturbances
- Diabetes
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dep. of anesthesiology, Hospital of Frederikssund
Frederikssund, 3600
Jon Jacobsen
Frederikssund, DK 3600
About this study
Official title: Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine?
The purpose of the study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade.
- Conditions
- Spinal Anesthesia
- Being tested
- Lidocaine, bupivacaine
- Keywords
- Spinal anaesthesia, Bupivacaine, Lidocaine, Duration of blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
bupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | Bupivacaine as used routinely Receives: Drug: bupivacaine |
| Lidocaine added to bupivacaine | Placebo comparator | lidocaine is added to bupivacaine Receives: Drug: Lidocaine; Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of spinal blockade
Measured: Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.
Secondary outcomes (1)
Time to fulfillment of discharge criteria from the hospital.
Measured: Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederikssunds Hospital, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Jacobsen, Frederikssunds Hospital, Denmark
- Investigators
- Jon Jacobsen, M.D., Principal investigator, Frederikssunds Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245868
- Sponsor's protocol ID
- FRS-AN2009-03-09
- Status last verified
- May 2015
- First submitted
- 14 Jun 2010
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine?
- ClinicalTrials.gov ID
- NCT01245868
- Acronym / sponsor ID
- FRS-AN2009-03-09
- Conditions
- Spinal Anesthesia
- Keywords
- Spinal anaesthesia, Bupivacaine, Lidocaine, Duration of blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Frederikssunds Hospital, DenmarkUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Nov 2010 (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 study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: bupivacaineBupivacaine as used routinely |
| Lidocaine added to bupivacaine | Placebo comparator | Drug: Lidocaine, Drug: bupivacainelidocaine is added to bupivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient want spinal anaesthesia
- No contradictions against spinal anaesthesia
- Healthy people (ASA-score 1 or 2)
- Body mass index < 35 and between 155 and 190 cm
Key exclusion criteria (3 listed)
- Known allergic reactions to planned drugs
- Neurologic disturbances
- Diabetes
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 |
|---|---|---|
| Lidocaine | Drug | Lidocaine added to bupivacaine |
| bupivacaine | Drug | Bupivacaine, Lidocaine added to bupivacaine |
Primary outcome
Duration of spinal blockade
Time frame: Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.
1 secondary outcome
Time to fulfillment of discharge criteria from the hospital.
Time frame: Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes.
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 8 May 2015.
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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.
Jon Jacobsen, M.D. principal investigator
Frederikssunds Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and bupivacaine in people with Spinal Anesthesia, run by Frederikssunds Hospital, Denmark at 2 sites in Denmark.
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 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 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Duration of spinal blockade (time frame: Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.). 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 8 May 2015.