Hip SurgeryNCT01875289
Efficacy of a Modified Obturator Nerve Block Technique
A study testing obturator nerve block in people with Hip Surgery and Knee Surgery, run by Medical University of Graz at 1 site in Austria.
Trial summary
Efficacy of a modified obturator nerve block technique by using only a single morphological landmark, a double-blinded randomised pilot study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Surgery, Knee Surgery
- What is being tested?
- obturator nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2013to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists 1-3, older than 18 y, cooperative patient
Who cannot join
- infection, neuromuscular deficits of the lower extremities,pregnancy, neurologic disease
Trial locations and contacts
1 site in 1 country.
About this study
Efficacy of a modified obturator nerve block technique by using only a single morphological landmark, a double-blinded randomised pilot study.
- Conditions
- Hip Surgery, Knee Surgery
- Being tested
- obturator nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obturator nerve blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ropivacain | Experimental | Local anaesthesia Receives: Procedure: obturator nerve block |
| NaCl 0.9% | Placebo comparator | Saline Receives: Procedure: obturator nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adductor strengths
Adductor muscle strength is measured with a sphygmomanometer. Patients are instructed to squeeze a blod pressure cuff, already inflated to 40 mm Hg, between their extended knees. The maximal sustained pressure is taken as the baseline adductor strength.
Measured: pre operative, 30 minutes before start surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
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 Hip SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Sandner-Kiesling , MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875289
- Sponsor's protocol ID
- VOB-Studie EK 25-387 ex 12/13
- Status last verified
- Mar 2014
- First submitted
- 7 Jun 2013
- Last updated
- 21 Mar 2014
- Results posted
- No
Publications
Feigl GC, Ulz H, Pixner T, Dolcet C, Likar R, Sandner-Kiesling A. Anatomical investigation of a new vertical obturator nerve block technique. Ann Anat. 2013 Jan;195(1):82-7. doi: 10.1016/j.aanat.2012.05.008. Epub 2012 Aug 10.
PubMed 22951254
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Modified Obturator Nerve Block Technique
- ClinicalTrials.gov ID
- NCT01875289
- Acronym / sponsor ID
- VOB-Studie EK 25-387 ex 12/13
- Conditions
- Hip Surgery, Knee Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 11 Jun 2013 (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.
Efficacy of a modified obturator nerve block technique by using only a single morphological landmark, a double-blinded randomised pilot study.
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 |
|---|---|---|
| Ropivacain | Experimental | Procedure: obturator nerve blockLocal anaesthesia |
| NaCl 0.9% | Placebo comparator | Procedure: obturator nerve blockSaline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists 1-3, older than 18 y, cooperative patient
Key exclusion criteria (1 listed)
- infection, neuromuscular deficits of the lower extremities,pregnancy, neurologic disease
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 |
|---|---|---|
| obturator nerve block | Procedure or surgery | NaCl 0.9%, Ropivacain |
Primary outcome
Adductor strengths
Time frame: pre operative, 30 minutes before start surgery
Adductor muscle strength is measured with a sphygmomanometer. Patients are instructed to squeeze a blod pressure cuff, already inflated to 40 mm Hg, between their extended knees. The maximal sustained pressure is taken as the baseline adductor strength.
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 21 Mar 2014.
- Background: PubMed 22951254Feigl GC, Ulz H, Pixner T, Dolcet C, Likar R, Sandner-Kiesling A. Anatomical investigation of a new vertical obturator nerve block technique. Ann Anat. 2013 Jan;195(1):82-7. doi: 10.1016/j.aanat.2012.05.008. Epub 2012 Aug 10.
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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.
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 study testing obturator nerve block in people with Hip Surgery and Knee Surgery, run by Medical University of Graz at 1 site in Austria.
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 1 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 21 Mar 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 Austria. 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.
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?
Adductor strengths (time frame: pre operative, 30 minutes before start 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 NCT01875289, 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 21 Mar 2014.