Inguinal HerniaPhase 4NCT01326039
Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair
A Phase 4 study testing bupivacaine and saline in people with Inguinal Hernia, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- bupivacaine and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- May 2010to 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 18 years
- unilateral primary inguinal repair
- open surgery a.m. Lichtenstein
- informed consent
Who cannot join
- age below 18 years
- secondary surgery
- laparoscopic surgery
- lack of communicative skills
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Bispebjerg
Copenhagen, NV, 2400
Finn Bærentzen, MD, 35313531, finn-baerentzen@tdcadsl.dk
Kenneth Jensen, MD, 35313531 ext. 4496, kjen0067@bbh.regionh.dk
About this study
Official title: Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?
Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.
- Conditions
- Inguinal Hernia
- Being tested
- bupivacaine, saline
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
perineural bupivacaine 5 mg/ml 20 ml
salineDrug
perineural isotonic saline 20 ml
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Active comparator | perineural bupivacaine 5 mg/ml 20 ml Receives: Drug: bupivacaine |
| saline | Placebo comparator | perineural isotonic saline 20 ml Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain at mobilization using 100 mm VAS
Measured: within the first 24 hours postoperatively
Secondary outcomes (4)
pain at rest using 100 mm VAS
Measured: within 24 hours postoperatively
perceived illness
using short form-8 index
Measured: within 24 hours postoperatively
ability of daily living
using the Barthel/100 index
Measured: within 24 hours
amount of analgesics
Measured: within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Jensen, MD, Study chair, Copenhagen University Hospital Bispebjerg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326039
- Sponsor's protocol ID
- BBH_2010_IIH
- Status last verified
- Apr 2010
- First submitted
- 28 Mar 2011
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?
- ClinicalTrials.gov ID
- NCT01326039
- Acronym / sponsor ID
- BBH_2010_IIH
- Conditions
- Inguinal Hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 30 Mar 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.
Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.
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 |
|---|---|---|
| bupivacaine | Active comparator | Drug: bupivacaineperineural bupivacaine 5 mg/ml 20 ml |
| saline | Placebo comparator | Drug: salineperineural isotonic saline 20 ml |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age above 18 years
- unilateral primary inguinal repair
- open surgery a.m. Lichtenstein
- informed consent
Key exclusion criteria (4 listed)
- age below 18 years
- secondary surgery
- laparoscopic surgery
- lack of communicative skills
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 |
|---|---|---|
| bupivacaineperineural bupivacaine 5 mg/ml 20 ml | Drug | bupivacaine |
| salineperineural isotonic saline 20 ml | Drug | saline |
Primary outcome
pain at mobilization using 100 mm VAS
Time frame: within the first 24 hours postoperatively
4 secondary outcomes
pain at rest using 100 mm VAS
Time frame: within 24 hours postoperatively
perceived illness
Time frame: within 24 hours postoperatively
ability of daily living
Time frame: within 24 hours
amount of analgesics
Time frame: within 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
Kenneth Jensen, MD study chair
Copenhagen University Hospital Bispebjerg, Denmark
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 bupivacaine and saline in people with Inguinal Hernia, run by Bispebjerg Hospital 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 4 inclusion and 4 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 30 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain at mobilization using 100 mm VAS (time frame: within the first 24 hours postoperatively). 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 30 Mar 2011.