PainPhase 4NCT01356797
Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery
A Phase 4 study testing hypobaric levobupivacaine with fentanyl and hyperbaric bupivacaine 0,5% in people with Pain, run by USP Hospital La Colina at 1 site in Spain.
Trial summary
Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been validated for this surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- hypobaric levobupivacaine with fentanyl and hyperbaric bupivacaine 0,5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- May 2011to Sep 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults scheduled to undergo knee arthroscopy
Who cannot join
- a previous history of neurological impairment
- insulin-dependent diabetes mellitus
- intolerance to the study drug or related compounds and additives
- BMI > 38 kg/m2
- height <155 cm or >180 cm
- any existing contraindications for spinal anaesthesia
- surgery in which a complete block of the lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been validated for this surgery. Both selective techniques are specially indicated for ambulatory surgery because of PACU fast track, low discharge home time and high patient satisfaction. This study compares both spinal techniques for knee arthroscopy surgery.
- Conditions
- Pain
- Being tested
- hypobaric levobupivacaine with fentanyl, hyperbaric bupivacaine 0,5%
- Keywords
- knee arthroscopy, hyperbaric bupivacaine, hypobaric levobupivacaine plus fentanyl
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypobaric levobupivacaine with fentanylDrug
Also called Chirocane
SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl
hyperbaric bupivacaine 0,5%Drug
Also called Marchaine
SUSA with 4 mg hyperbaric bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric bupivacaine | Active comparator | Not described Receives: Drug: hyperbaric bupivacaine 0,5% |
| hypobaric levobupivacaine with fentanyl | Experimental | Not described Receives: Drug: hypobaric levobupivacaine with fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to discharge home
In Day Surgery Unit, patients will be assessed for home discharge every 30 minutes and will be followed an expected average of three hours.
Measured: every 30 minutes for an average of 3 hours
Secondary outcomes (1)
Ambulation time after surgery
In PACU and in Day Surgery Unit, patients will be assessed for unassisted ambulation every 30 minutes and will be followed an expected average of three hours.
Measured: every 30 minutes for an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- USP Hospital La Colina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus de Santiago Moragas, USP Hospital La Colina
- Investigators
- Jesus Santiago Moragas, Principal investigator, USP La ColinaJavier Santos-Yglesias, Study chair, Department of Anesthesiology, Hospital La colina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356797
- Sponsor's protocol ID
- SUAK-1
- Status last verified
- Sep 2011
- First submitted
- 10 May 2011
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery
- ClinicalTrials.gov ID
- NCT01356797
- Acronym / sponsor ID
- SUAK-1
- Conditions
- Pain
- Keywords
- knee arthroscopy, hyperbaric bupivacaine, hypobaric levobupivacaine plus fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- USP Hospital La ColinaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 May 2011 (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.
Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been validated for this surgery. Both selective techniques are specially indicated for ambulatory surgery because of PACU fast track, low discharge home time and high patient satisfaction. This study compares both spinal techniques for knee arthroscopy surgery.
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 |
|---|---|---|
| hyperbaric bupivacaine | Active comparator | Drug: hyperbaric bupivacaine 0,5% |
| hypobaric levobupivacaine with fentanyl | Experimental | Drug: hypobaric levobupivacaine with fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults scheduled to undergo knee arthroscopy
Key exclusion criteria (7 listed)
- a previous history of neurological impairment
- insulin-dependent diabetes mellitus
- intolerance to the study drug or related compounds and additives
- BMI > 38 kg/m2
- height <155 cm or >180 cm
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 |
|---|---|---|
| hypobaric levobupivacaine with fentanylAlso: ChirocaneSSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl | Drug | hypobaric levobupivacaine with fentanyl |
| hyperbaric bupivacaine 0,5%Also: MarchaineSUSA with 4 mg hyperbaric bupivacaine 0.5% | Drug | hyperbaric bupivacaine |
Primary outcome
time to discharge home
Time frame: every 30 minutes for an average of 3 hours
In Day Surgery Unit, patients will be assessed for home discharge every 30 minutes and will be followed an expected average of three hours.
1 secondary outcome
Ambulation time after surgery
Time frame: every 30 minutes for an average of 3 hours
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 9 Sep 2011.
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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.
Jesus Santiago Moragas principal investigator
USP La Colina
Javier Santos-Yglesias study chair
Department of Anesthesiology, Hospital La colina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hypobaric levobupivacaine with fentanyl and hyperbaric bupivacaine 0,5% in people with Pain, run by USP Hospital La Colina at 1 site in Spain.
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 7 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 9 Sep 2011. 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 Spain. 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 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?
time to discharge home (time frame: every 30 minutes for an average of 3 hours). 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 9 Sep 2011.