Arthroscopic ACL RerpairNCT02186899
Peripheral Nerve Block (Femoral - Sciatic - Obturator) Versus General Anesthesia for Arthroscopic ACL Repair
A study testing Ultrasound Guided Femoral Sciatic Obturator nerve blocks, General Anesthesia femoral bolus and General anesthesia femoral continuous in people with Arthroscopic ACL Rerpair and Surgery, run by Larissa University Hospital at 1 site in Greece.
Trial summary
Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few years peripheral nerve blocks have increased their popularity for this kind of operation. The investigators want to see how the type of anesthesia and postoperative analgesia effects the time required for patient mobilisation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroscopic ACL Rerpair, Surgery, Anesthesia Care
- What is being tested?
- Ultrasound Guided Femoral Sciatic Obturator nerve blocks, General Anesthesia femoral bolus and General anesthesia femoral continuous
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2014to Dec 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 yrs
- ASA I - III
- ACL surgery
Who cannot join
- Coagulopathy disorders
- Infection at the puncture site for the interscalene block
- Neurologic deficit in the arm that is going to be operated
- Allergy to local anesthetics
- BMI > 35
- Psychiatric disorders
- Patient's refusal
- Problems with patient communication
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Private Clinic of Larissa "Asklipeiio"
Larissa, Larissa
Marina Simaioforidou, Medicine
Marina Simaioforidou, Medicine
About this study
Official title: Comparison of Femoral - Sciatic - Obturator Nerve Block vs General Anesthesia in Combination With Continuous or Bolus Femoral Nerve Block for Arthroscopic ACL Repair Regarding the Time of Patient Mobilasation
Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few years peripheral nerve blocks have increased their popularity for this kind of operation. The investigators want to see how the type of anesthesia and postoperative analgesia effects the time required for patient mobilisation.
- Conditions
- Arthroscopic ACL Rerpair, Surgery, Anesthesia Care
- Being tested
- Ultrasound Guided Femoral Sciatic Obturator nerve blocks, General Anesthesia femoral bolus, General anesthesia femoral continuous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Femoral Sciatic Obturator nerve blocksOther
General Anesthesia femoral bolusOther
General anesthesia femoral continuousOther
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia Femoral continuous | Active comparator | General anesthesia plus continuous femoral nerve block Receives: Other: General anesthesia femoral continuous |
| General anesthesia Femoral bolus | Active comparator | General anesthesia plus single shot femoral nerve block Receives: Other: General Anesthesia femoral bolus |
| Femoral Sciatic Obturator Nerve block | Active comparator | Ultrasound guided femoral plus sciatic plus obturator nerve block Receives: Other: Ultrasound Guided Femoral Sciatic Obturator nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery completed without pain for the patient
Use of VAS score
Measured: Completion of the surgery
Postoperative pain
Use of VAS score
Measured: 1st postoperative day
Secondary outcomes (1)
Mobilization of the knee
How many degrees can the patient bend the knee
Measured: 24 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic ACL RerpairStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Simaioforidou, Larissa University Hospital
- Investigators
- Marina Simaioforidou, Medicine, Study director, Private Clinic of Larissa "Asklipeiio"George Basdekis, Medicine, Study chair, Private Clinic of Larissa "Asklipeiio"Konstantinos Bargiotas, Medicine, Study chair, Larissa University HospitalAristeidis Zibis, Medicine, Study chair, Private Clinic of Larissa "Askipeiio"Athanasios Drakos, Medicine, Study chair, Larissa University HospitalMetaxia Bareka, Medicine, Principal investigator, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186899
- Sponsor's protocol ID
- FSOvsGA
- Status last verified
- Jul 2014
- First submitted
- 27 Apr 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Femoral - Sciatic - Obturator Nerve Block vs General Anesthesia in Combination With Continuous or Bolus Femoral Nerve Block for Arthroscopic ACL Repair Regarding the Time of Patient Mobilasation
- ClinicalTrials.gov ID
- NCT02186899
- Acronym / sponsor ID
- FSOvsGA
- Conditions
- Arthroscopic ACL Rerpair, Surgery, Anesthesia Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Jul 2014 (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.
Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few years peripheral nerve blocks have increased their popularity for this kind of operation. The investigators want to see how the type of anesthesia and postoperative analgesia effects the time required for patient mobilisation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Femoral continuous | Active comparator | Other: General anesthesia femoral continuousGeneral anesthesia plus continuous femoral nerve block |
| General anesthesia Femoral bolus | Active comparator | Other: General Anesthesia femoral bolusGeneral anesthesia plus single shot femoral nerve block |
| Femoral Sciatic Obturator Nerve block | Active comparator | Other: Ultrasound Guided Femoral Sciatic Obturator nerve blocksUltrasound guided femoral plus sciatic plus obturator nerve block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 80 yrs
- ASA I - III
- ACL surgery
Key exclusion criteria (8 listed)
- Coagulopathy disorders
- Infection at the puncture site for the interscalene block
- Neurologic deficit in the arm that is going to be operated
- Allergy to local anesthetics
- BMI > 35
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 |
|---|---|---|
| Ultrasound Guided Femoral Sciatic Obturator nerve blocks | Other | Femoral Sciatic Obturator Nerve block |
| General Anesthesia femoral bolus | Other | General anesthesia Femoral bolus |
| General anesthesia femoral continuous | Other | General Anesthesia Femoral continuous |
Primary outcome
Surgery completed without pain for the patient
Time frame: Completion of the surgery
Use of VAS score
Postoperative pain
Time frame: 1st postoperative day
Use of VAS score
1 secondary outcome
Mobilization of the knee
Time frame: 24 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
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.
Marina Simaioforidou, Medicine study director
Private Clinic of Larissa "Asklipeiio"
George Basdekis, Medicine study chair
Private Clinic of Larissa "Asklipeiio"
Konstantinos Bargiotas, Medicine study chair
Larissa University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Femoral Sciatic Obturator nerve blocks, General Anesthesia femoral bolus and General anesthesia femoral continuous in people with Arthroscopic ACL Rerpair and Surgery, run by Larissa University Hospital at 1 site in Greece.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Jul 2014. 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 Greece. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Simaioforidou, Medicine (00306947845083, msimaiof@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery completed without pain for the patient (time frame: Completion of the surgery). The study lists 2 primary outcomes in all. 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 10 Jul 2014.