Total Knee ReplacementNCT01755117
Ultrasound Guided Obturator Nerve Block for Total Knee Replacement (TKR)
A study testing Sciatic, femoral, obturator nerve blocks and Sciatic nerve block, posterior lumbar plexus block in people with Total Knee Replacement and Surgery, run by Larissa University Hospital at 1 site in Greece.
Trial summary
Total Knee Replacement can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Replacement, Surgery
- What is being tested?
- Sciatic, femoral, obturator nerve blocks and Sciatic nerve block, posterior lumbar plexus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2012to Dec 2014
- 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
- TKR 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
Larissa University Hospital
Larissa, Thessally, 41110
Metaxia Bareka, Medicine, 00306947845083 ext. 1370, barekametaxia@hotmail.com
George Vretzakis, Medicine, 00302413502952 ext. 2952, gvretzakis@yahoo.com
About this study
Official title: Comparison of Posterior Lumbar Plexus Block Plus Sciatic Nerve Block With Sciatic Plus Femoral Plus Obturator Nerve Block for Total Knee Replacement (TKR)
Total Knee Replacement can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve block.
- Conditions
- Total Knee Replacement, Surgery
- Being tested
- Sciatic, femoral, obturator nerve blocks, Sciatic nerve block, posterior lumbar plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic, femoral, obturator nerve blocksOther
Also called Ultrasound guided blocks with ropivacaine
Sciatic nerve block, posterior lumbar plexus blockOther
Also called Ultrasound guided blocks with ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| TKR, sciatic, femoral, obturator | Active comparator | TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block Receives: Other: Sciatic, femoral, obturator nerve blocks |
| TKR sciatic nerve block, posterior lumbar plexus block | Active comparator | TKR surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus block Receives: Other: Sciatic nerve block, posterior lumbar plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block measured with Pain Score on the Visual Analog Scale
If the patient complains for pain > 4 in VAS and there is no relief with fentanyl administration the anesthesia plan converts to general anesthesia with laryngeal mask
Measured: Completion of surgery
Secondary outcomes (1)
Intraoperative opioid consumption for TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
Measured: Intaoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- None (open label)
- Enrolment
- 100 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, Principal investigator, Larissa University HospitalMetaxia Bareka, Medicine, Study chair, Larissa University HospitalGeorge Basdekis, Medicine, Study chair, Larissa University HospitalAthanasios Drakos, Medicine, Study chair, Larissa University HospitalAristeidis Zibis, Medicine, Study chair, Private Clinic of Larissa AsklipeiioKonstantinos Alexiou, Medicine, Study chair, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755117
- Sponsor's protocol ID
- TKR obturator
- Status last verified
- Apr 2014
- First submitted
- 18 Dec 2012
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Enneking FK, Chan V, Greger J, Hadzic A, Lang SA, Horlocker TT. Lower-extremity peripheral nerve blockade: essentials of our current understanding. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):4-35. doi: 10.1016/j.rapm.2004.10.002. No abstract available.
PubMed 15690265
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posterior Lumbar Plexus Block Plus Sciatic Nerve Block With Sciatic Plus Femoral Plus Obturator Nerve Block for Total Knee Replacement (TKR)
- ClinicalTrials.gov ID
- NCT01755117
- Acronym / sponsor ID
- TKR obturator
- Conditions
- Total Knee Replacement, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Dec 2012 (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.
Total Knee Replacement can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKR, sciatic, femoral, obturator | Active comparator | Other: Sciatic, femoral, obturator nerve blocksTKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block |
| TKR sciatic nerve block, posterior lumbar plexus block | Active comparator | Other: Sciatic nerve block, posterior lumbar plexus blockTKR surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus 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
- TKR 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 |
|---|---|---|
| Sciatic, femoral, obturator nerve blocksAlso: Ultrasound guided blocks with ropivacaine | Other | TKR, sciatic, femoral, obturator |
| Sciatic nerve block, posterior lumbar plexus blockAlso: Ultrasound guided blocks with ropivacaine | Other | TKR sciatic nerve block, posterior lumbar plexus block |
Primary outcome
Feasibility of TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block measured with Pain Score on the Visual Analog Scale
Time frame: Completion of surgery
If the patient complains for pain > 4 in VAS and there is no relief with fentanyl administration the anesthesia plan converts to general anesthesia with laryngeal mask
1 secondary outcome
Intraoperative opioid consumption for TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block
Time frame: Intaoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Background: PubMed 15690265Enneking FK, Chan V, Greger J, Hadzic A, Lang SA, Horlocker TT. Lower-extremity peripheral nerve blockade: essentials of our current understanding. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):4-35. doi: 10.1016/j.rapm.2004.10.002. No abstract available.
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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.
Marina Simaioforidou, Medicine principal investigator
Larissa University Hospital
Metaxia Bareka, Medicine study chair
Larissa University Hospital
George Basdekis, 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 Sciatic, femoral, obturator nerve blocks and Sciatic nerve block, posterior lumbar plexus block in people with Total Knee Replacement 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 29 Apr 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 Metaxia Bareka, Medicine (00306947845083 ext. 1370, barekametaxia@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block measured with Pain Score on the Visual Analog Scale (time frame: Completion of surgery). 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 NCT01755117, which also lists 1 linked publication.
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 29 Apr 2014.