Inguinal HerniaPVBNCT00587704
Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair
A study testing PVB using nerve stimulation and PVB using anatomic landmarks in people with Inguinal Hernia, run by Mayo Clinic at 1 site in United States.
Trial summary
Primary aim: 1. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair. Secondary aims: 1. Compare VAS pain scores in the two groups of patients over the first 24 hours. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- PVB using nerve stimulation and PVB using anatomic landmarks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral open inguinal herniorrhaphy
- Patient must be >18 years of age
- ASA physical status of I, II, or III
- Patient competent to provide informed consent
Who cannot join
- Patient < 18 years of age
- Pregnant or lactating women
- Patient unwilling or unable to provide informed consent
- Contraindications to regional anesthesia
- Allergy to amide local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paravertebral Blocks Techniques: A Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks for Patients Undergoing Inguinal Hernia Repair
Primary aim:
- To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair.
Secondary aims:
- Compare VAS pain scores in the two groups of patients over the first 24 hours.
- Compare opioid intake over the first 24 hours in the two groups of patients.
- Conditions
- Inguinal Hernia
- Being tested
- PVB using nerve stimulation, PVB using anatomic landmarks
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVB using nerve stimulationProcedure or surgery
5ml of 1% ropivacaine injected incrementally
PVB using anatomic landmarksProcedure or surgery
5ml of 1% ropivacaine injected incrementally
| Study group | Role | What they receive |
|---|---|---|
| Nerve Stimulation | Other | Use of nerve stimulator for placement of PVB nerve block Receives: Procedure: PVB using nerve stimulation |
| Anatomic landmarks | Other | Use of anatomic landmarks for placement of PVB block Receives: Procedure: PVB using anatomic landmarks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful full block at T11-L1
Measured: Every 10 minutes until full block achieved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Steven R. Clendenen, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587704
- Sponsor's protocol ID
- 07-002759
- Acronym
- PVB
- Status last verified
- Feb 2010
- First submitted
- 21 Dec 2007
- Last updated
- 23 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Blocks Techniques: A Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks for Patients Undergoing Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT00587704
- Acronym / sponsor ID
- PVB / 07-002759
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Jan 2008 (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.
Primary aim:
- To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair.
Secondary aims:
- Compare VAS pain scores in the two groups of patients over the first 24 hours.
- Compare opioid intake over the first 24 hours in the two groups of patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Stimulation | Other | Procedure: PVB using nerve stimulationUse of nerve stimulator for placement of PVB nerve block |
| Anatomic landmarks | Other | Procedure: PVB using anatomic landmarksUse of anatomic landmarks for placement of PVB block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral open inguinal herniorrhaphy
- Patient must be >18 years of age
- ASA physical status of I, II, or III
- Patient competent to provide informed consent
Key exclusion criteria (5 listed)
- Patient < 18 years of age
- Pregnant or lactating women
- Patient unwilling or unable to provide informed consent
- Contraindications to regional anesthesia
- Allergy to amide local anesthetics
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 |
|---|---|---|
| PVB using nerve stimulation5ml of 1% ropivacaine injected incrementally | Procedure or surgery | Nerve Stimulation |
| PVB using anatomic landmarks5ml of 1% ropivacaine injected incrementally | Procedure or surgery | Anatomic landmarks |
Primary outcome
Successful full block at T11-L1
Time frame: Every 10 minutes until full block achieved
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 23 Feb 2010.
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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.
Steven R. Clendenen, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVB using nerve stimulation and PVB using anatomic landmarks in people with Inguinal Hernia, run by Mayo Clinic 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 4 inclusion and 5 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 23 Feb 2010. 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. 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?
Successful full block at T11-L1 (time frame: Every 10 minutes until full block achieved). 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 23 Feb 2010.