Knee ArthritisPhase 4NCT02384915
Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy
A Phase 4 study testing prilocaine, mepivacaine and Sciatic-femoral Nerve Block in people with Knee Arthritis, run by ASST Gaetano Pini-CTO at 1 site in Italy.
Trial summary
The aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- prilocaine, mepivacaine and Sciatic-femoral Nerve Block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to May 2015
- 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
- outpatients knee arthroscopy
Who cannot join
- diabetes
- allergy to local anesthetic
- patient refusal
- chronic opiods assumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato
The aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy
Read the detailed description
Two groups: the first receive a spinal anesthesia injecting 2% hyperbaric prilocaine 40 mg with the patients in lateral decubitus and the surgical limb declive, the second a combined ultrasound-guided sciatic-femoral nerve block injecting 25 ml of 2% mepivacaine solution.
Onset time, performance time, duration of the block, time of voiding, as well as the time of home discharge will be evaluated.
- Conditions
- Knee Arthritis
- Being tested
- prilocaine, mepivacaine, Sciatic-femoral Nerve Block, Spinal anesthesia, Sonoplex, Pajunk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prilocaineDrug
Also called prilotekal
mepivacaineDrug
Also called carbocaine
Sciatic-femoral Nerve BlockProcedure or surgery
ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve
Spinal anesthesiaProcedure or surgery
intrathecal injection of 40 mg hyperbaric prilocaine
Sonoplex, PajunkDevice
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Experimental | Intrathecal injection of 2 ml (40 mg) of 2% hyperbaric prilocaine at L3-L4 interspaces through a 100mm Sprotte 25 G spinal needle (Pencan, b-brawn, Germay) in lateral decubitus position, (with limb to operate declive). Receives: Drug: prilocaine; Procedure: Spinal anesthesia |
| peripheral nerve block | Active comparator | Ultrasound-guided sciatic-femoral nerve block injecting 25 ml of a 2% mepivacaine solution,15 ml on femoral nerve and 10 ml on sciatic nerve through a 80 mm 22g eco-reflex needle (Sonoplex, Pajunk, Germany) Receives: Drug: mepivacaine; Procedure: Sciatic-femoral Nerve Block; Device: Sonoplex, Pajunk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to home discharge
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Cappelleri, ASST Gaetano Pini-CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384915
- Sponsor's protocol ID
- IOGPGC07
- Status last verified
- Mar 2015
- First submitted
- 20 Feb 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato
- ClinicalTrials.gov ID
- NCT02384915
- Acronym / sponsor ID
- IOGPGC07
- Conditions
- Knee Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Mar 2015 (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 aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy
Detailed description
Two groups: the first receive a spinal anesthesia injecting 2% hyperbaric prilocaine 40 mg with the patients in lateral decubitus and the surgical limb declive, the second a combined ultrasound-guided sciatic-femoral nerve block injecting 25 ml of 2% mepivacaine solution.
Onset time, performance time, duration of the block, time of voiding, as well as the time of home discharge will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Experimental | Drug: prilocaine, Procedure: Spinal anesthesiaIntrathecal injection of 2 ml (40 mg) of 2% hyperbaric prilocaine at L3-L4 interspaces through a 100mm Sprotte 25 G spinal needle (Pencan, b-brawn, Germay) in lateral decubitus position, (with limb to operate declive). |
| peripheral nerve block | Active comparator | Drug: mepivacaine, Procedure: Sciatic-femoral Nerve Block, Device: Sonoplex, PajunkUltrasound-guided sciatic-femoral nerve block injecting 25 ml of a 2% mepivacaine solution,15 ml on femoral nerve and 10 ml on sciatic nerve through a 80 mm 22g eco-reflex needle (Sonoplex, Pajunk, Germany) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients knee arthroscopy
Key exclusion criteria (4 listed)
- diabetes
- allergy to local anesthetic
- patient refusal
- chronic opiods assumption
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 |
|---|---|---|
| prilocaineAlso: prilotekal | Drug | Spinal anesthesia |
| mepivacaineAlso: carbocaine | Drug | peripheral nerve block |
| Sciatic-femoral Nerve Blockultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve | Procedure or surgery | peripheral nerve block |
| Spinal anesthesiaintrathecal injection of 40 mg hyperbaric prilocaine | Procedure or surgery | Spinal anesthesia |
| Sonoplex, Pajunk | Device | peripheral nerve block |
Primary outcome
Time to home discharge
Time frame: 12 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 8 May 2015.
Related trials for Knee Arthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 prilocaine, mepivacaine and Sciatic-femoral Nerve Block in people with Knee Arthritis, run by ASST Gaetano Pini-CTO at 1 site in Italy.
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 4 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 1 site in Italy. 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 home discharge (time frame: 12 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 8 May 2015.