PainPhase 4NCT01373593
Ultrasound Guided Blocks of the Iliohypogastric and Ilioinguinal Nerves in Persistent Postherniorrhaphy Pain Patients
A Phase 4 study testing lidocaine in people with Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
In this controlled study the investigators will examine the analgesic and sensory effects of ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in persistent postherniorrhaphy pain patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Jul 2011
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients older than 18 years with severe postherniorrhaphy pain (numerical rating scale [NRS] > 6) for more than 6 month
Who cannot join
- known amide local anesthetic drug allergy
- recurrent hernia
Trial locations and contacts
1 site in 1 country.
About this study
In this controlled study the investigators will examine the analgesic and sensory effects of ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in persistent postherniorrhaphy pain patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | lidocaine block Receives: Drug: lidocaine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes (lidocaine vs. placebo) in pain perception, sensory mapping and QST compared to pre-block values.
Measured: 20 minutes after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
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 PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373593
- Sponsor's protocol ID
- H-1-2010-116
- Status last verified
- Jan 2011
- First submitted
- 8 Jun 2011
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bischoff JM, Koscielniak-Nielsen ZJ, Kehlet H, Werner MU. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks for persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial. Anesth Analg. 2012 Jun;114(6):1323-9. doi: 10.1213/ANE.0b013e31824d6168. Epub 2012 Mar 30.
PubMed 22467891
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Blocks of the Iliohypogastric and Ilioinguinal Nerves in Persistent Postherniorrhaphy Pain Patients
- ClinicalTrials.gov ID
- NCT01373593
- Acronym / sponsor ID
- H-1-2010-116
- Conditions
- Pain
- Keywords
- persistent postherniorrhaphy pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Jun 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.
In this controlled study the investigators will examine the analgesic and sensory effects of ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in persistent postherniorrhaphy pain patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Drug: lidocainelidocaine block |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients older than 18 years with severe postherniorrhaphy pain (numerical rating scale [NRS] > 6) for more than 6 month
Key exclusion criteria (2 listed)
- known amide local anesthetic drug allergy
- recurrent hernia
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 |
|---|---|---|
| lidocaine | Drug | lidocaine |
| Placebo | Drug | Placebo |
Primary outcome
changes (lidocaine vs. placebo) in pain perception, sensory mapping and QST compared to pre-block values.
Time frame: 20 minutes after the block
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Derived from this study: PubMed 22467891Bischoff JM, Koscielniak-Nielsen ZJ, Kehlet H, Werner MU. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks for persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial. Anesth Analg. 2012 Jun;114(6):1323-9. doi: 10.1213/ANE.0b013e31824d6168. Epub 2012 Mar 30.
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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 Phase 4 study testing lidocaine in people with Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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: stopped early, as of the sponsor's last update on 20 Jun 2012. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
changes (lidocaine vs. placebo) in pain perception, sensory mapping and QST compared to pre-block values. (time frame: 20 minutes after the block). 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 NCT01373593, 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 20 Jun 2012.