Post Operative Pain as Estimated by the Sue of the VAS ScorePhase 2NCT01969006
Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair
A Phase 2 study testing Marcaine ½% and Needle prick in people with Post Operative Pain as Estimated by the Sue of the VAS Score, run by Randers Regional Hospital at 2 sites in Denmark.
Trial summary
This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair. Patients will be randomised to injection of Marcaine© og a needle prick per-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Post Operative Pain as Estimated by the Sue of the VAS Score
- What is being tested?
- Marcaine ½% and Needle prick
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2014to Jan 2015
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year
- Informed consent
- a diagnosis of an inguinal hernia
- ASA group ≤ 3
- BMI ≤ 35
Who cannot join
- Communication problems
- No consent
- Open procedure (not laparoscopic)
- ASA-group 4
- Use of Steroid or immunosuppressive tretament
- Regular morphine use.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Horsens Regions Hospital
Horsens, 8700
Randers regions Hospital
Randers, 8900
About this study
Official title: Effect of Ilioinguinal Blockage on Postoperative Pain After Laparoscopic Inguinal Herna Repair
This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair.
Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.
Pain will be estimated using the VAS score in:
- the wound 2 the abdomen 3 the shoulder
Scoring will be performed:
- pre-operatively
- 1 hour postoperatively
- at discharge from the hospital d day 1,2 and 3 post OP
- 1 year post OP
Read the detailed description
as above
- Being tested
- Marcaine ½%, Needle prick
- Keywords
- inguinal hernia, postoperative pain, localanesthesia, nerve blockage
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine ½%Drug
Needle prickProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Injection of Marcaine ½ % | Experimental | Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine Receives: Drug: Marcaine ½% |
| Needle prick | Placebo comparator | Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine Receives: Procedure: Needle prick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
VAS score of pain from:
- wound
- abdomen
- shoulder
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
Why it stopped: Another study has been planned, so we did not initiate this one.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain as Estimated by the Sue of the VAS ScoreStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Randers Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Horsens, Denmark
- Responsible party
- Principal investigator, Thorbjorn Sommer, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969006
- Sponsor's protocol ID
- ILIOINGUINAL01
- Status last verified
- Oct 2013
- First submitted
- 21 Oct 2013
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ilioinguinal Blockage on Postoperative Pain After Laparoscopic Inguinal Herna Repair
- ClinicalTrials.gov ID
- NCT01969006
- Acronym / sponsor ID
- ILIOINGUINAL01
- Keywords
- inguinal hernia, postoperative pain, localanesthesia, nerve blockage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Another study has been planned, so we did not initiate this one.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Randers Regional HospitalUniversity, hospital or other
- Collaborators
- Regionshospitalet Horsens, Denmark
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- First posted
- 24 Oct 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.
This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair.
Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.
Pain will be estimated using the VAS score in:
- the wound 2 the abdomen 3 the shoulder
Scoring will be performed:
- pre-operatively
- 1 hour postoperatively
- at discharge from the hospital d day 1,2 and 3 post OP
- 1 year post OP
Detailed description
as above
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection of Marcaine ½ % | Experimental | Drug: Marcaine ½%Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine |
| Needle prick | Placebo comparator | Procedure: Needle prickNeedle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 year
- Informed consent
- a diagnosis of an inguinal hernia
- ASA group ≤ 3
- BMI ≤ 35
Key exclusion criteria (6 listed)
- Communication problems
- No consent
- Open procedure (not laparoscopic)
- ASA-group 4
- Use of Steroid or immunosuppressive tretament
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 |
|---|---|---|
| Marcaine ½% | Drug | Injection of Marcaine ½ % |
| Needle prick | Procedure or surgery | Needle prick |
Primary outcome
Post operative pain
Time frame: 1 year
VAS score of pain from: 1. wound 2. abdomen 3. shoulder
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Marcaine ½% and Needle prick in people with Post Operative Pain as Estimated by the Sue of the VAS Score, run by Randers Regional Hospital at 2 sites 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Post operative pain (time frame: 1 year). 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 17 Dec 2014.