Nerve Block; Pain MedicationNCT01409460
Obturator Nerve Block With Femoral and Sciatic Block
A study testing Oburator Nerve block in people with Nerve Block; Pain Medication, run by Trinity Health Of New England at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how many patients require the addition of the obturator nerve block in the recovery room after the total knee surgery. Also to study the efficacy of blocking the obturator nerve in controlling their knee pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nerve Block; Pain Medication
- What is being tested?
- Oburator Nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2009
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- total knee replacement
Who cannot join
- Hisory of neurologica disease, diabetes, pregnancy, neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: Is an Obturator Nerve Block Required for Every Patient Having Total Knee Arthroplasty With Femoral and Sciatic Nerve Block?
The purpose of this study is to evaluate how many patients require the addition of the obturator nerve block in the recovery room after the total knee surgery. Also to study the efficacy of blocking the obturator nerve in controlling their knee pain.
- Conditions
- Nerve Block; Pain Medication
- Being tested
- Oburator Nerve block, Sham Injection in pectineus muscle.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oburator Nerve blockProcedure or surgery
Use of selective pain block.
Sham Injection in pectineus muscle.Procedure or surgery
Five minutes after the sham block pain was assessed in these patients. If pain score was 5 or greater a true obturator nerve block was performed on these patients.
| Study group | Role | What they receive |
|---|---|---|
| True Obturator Nerve Block | Experimental | Not described Receives: Procedure: Oburator Nerve block |
| Sham Block | Sham comparator | Not described Receives: Procedure: Sham Injection in pectineus muscle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the use of obturator Nerve block for patients undergoing total knee arthroplasty
The need for rescue obturator nerve block in total knee arthoplasty patients who have sucessful femoral nerve block and sciatic nerve block in place.
Measured: 15 minutes in recovery room post operatively
Secondary outcomes (1)
Pain medication use intra-operatively and in the recovery room after surgery. Pain scores in recovery room.
Measured: During surgery and until discharge from recovery room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve Block; Pain MedicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409460
- Sponsor's protocol ID
- 08-10-003
- Status last verified
- Oct 2008
- First submitted
- 2 Aug 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is an Obturator Nerve Block Required for Every Patient Having Total Knee Arthroplasty With Femoral and Sciatic Nerve Block?
- ClinicalTrials.gov ID
- NCT01409460
- Acronym / sponsor ID
- 08-10-003
- Conditions
- Nerve Block; Pain Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Aug 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.
The purpose of this study is to evaluate how many patients require the addition of the obturator nerve block in the recovery room after the total knee surgery. Also to study the efficacy of blocking the obturator nerve in controlling their knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True Obturator Nerve Block | Experimental | Procedure: Oburator Nerve block |
| Sham Block | Sham comparator | Procedure: Sham Injection in pectineus muscle. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total knee replacement
Key exclusion criteria (1 listed)
- Hisory of neurologica disease, diabetes, pregnancy, neuropathy
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 |
|---|---|---|
| Oburator Nerve blockUse of selective pain block. | Procedure or surgery | True Obturator Nerve Block |
| Sham Injection in pectineus muscle.Five minutes after the sham block pain was assessed in these patients. If pain score was 5 or greater a true obturator nerve block was performed on these patients. | Procedure or surgery | Sham Block |
Primary outcome
To assess the use of obturator Nerve block for patients undergoing total knee arthroplasty
Time frame: 15 minutes in recovery room post operatively
The need for rescue obturator nerve block in total knee arthoplasty patients who have sucessful femoral nerve block and sciatic nerve block in place.
1 secondary outcome
Pain medication use intra-operatively and in the recovery room after surgery. Pain scores in recovery room.
Time frame: During surgery and until discharge from recovery room.
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 4 Aug 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.
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 Oburator Nerve block in people with Nerve Block; Pain Medication, run by Trinity Health Of New England at 1 site in United States.
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 4 Aug 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 United States. 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?
To assess the use of obturator Nerve block for patients undergoing total knee arthroplasty (time frame: 15 minutes in recovery room post operatively). 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 4 Aug 2011.