Hernia InguinalNCT01793571
Pilot Study on the Effectiveness of a TAP-block for Inguinal Hernia Repair
A study testing TAP block in people with Hernia Inguinal, run by Dijklander Ziekenhuis at 1 site in Netherlands.
Trial summary
An prospective double blinded randomised trial,whether the use of an perioperative echoguided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hernia Inguinal
- What is being tested?
- TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Mar 2013
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 80 year, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35.
Who cannot join
- fever, a coagulation disorder, patients with kidney and liverfaillure, an infection at the place where the puncture place, preoperative use of narcotic and nonsteroidal antiinflammatory drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study on the Effectiveness of the Echoguided Transversus Abdominis Plane Block During Inguinal Hernia Repair Surgery
An prospective double blinded randomised trial,whether the use of an perioperative echoguided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic.
Read the detailed description
Hernia inguinal repair is the most common operation performed by general surgeons in the Netherlands. On of the most common complications after hernia repair is postoperative and chronic pain. Postoperative pain is an expected but undesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return to full normal daily activities. There are indications that an insufficient treatment of postoperative pain is a risk factor for persistent or chronic pain after open inguinal hernia repair. Chronic pain is not uncommon after hernia repair, with an incidence of 11%.
The objective of this study is to determine, whether the use of an perioperative echo guided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic. There will be no further analysis in this study regarding the incidence of open hernia inguinal repair and chronic pain.
- Conditions
- Hernia Inguinal
- Being tested
- TAP block
- Keywords
- Abdominal Muscles/Ultrasonography, Adult, Ambulatory Surgical Procedures, Anesthetics, Local/Administration & Dosage, Levobupivacaine/Administration & Dosage, Levobupivacaine/Analogs & Derivatives, Hernia, Inguinal/Surgery, Humans, Nerve Block/Methods, Pain Measurement/Methods, Pain, Postoperative/Prevention & Control, Ultrasonography, Interventional
- Medical subject headings
- Hernia, Inguinal, Hernia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
2 groups, group A a TAP block with 20 ml of Levobupivacaine 0,5% and subcutaneous wound infiltration with 20 ml sodium chloride (to blind patient and physician) and group B, TAP block with 20 ml sodium chloride and subcutaneous wound infiltration with 20 ml Levobupivacaine 0,5% (to blind patient and physician)
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | 20 ml Levobupivacaine 0,5% Receives: Procedure: TAP block |
| Local wound infiltration | Active comparator | 20 ml levobupivacaine 0,5% Receives: Procedure: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation
Measured: 48 hours
Secondary outcomes (5)
time to to first use of intravenous morfine
Measured: 48 hours
the total amount of titrated postoperative morfine
Measured: 48 hours
use of tramadol at home
Measured: 48 hours
patient satisfaction
Measured: 48 hours
the incidence of nausea and vomiting
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia InguinalStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dijklander Ziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Dijkhuizen, Dijklander Ziekenhuis
- Investigators
- Jens P Hering, Anesthesiologist, Principal investigator, Dijklander Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793571
- Sponsor's protocol ID
- NL40460.094.12
- Status last verified
- Feb 2013
- First submitted
- 17 Jan 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effectiveness of the Echoguided Transversus Abdominis Plane Block During Inguinal Hernia Repair Surgery
- ClinicalTrials.gov ID
- NCT01793571
- Acronym / sponsor ID
- NL40460.094.12
- Conditions
- Hernia Inguinal
- Keywords
- Abdominal Muscles/Ultrasonography, Adult, Ambulatory Surgical Procedures, Anesthetics, Local/Administration & Dosage, Levobupivacaine/Administration & Dosage, Levobupivacaine/Analogs & Derivatives, Hernia, Inguinal/Surgery, Humans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dijklander ZiekenhuisUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 15 Feb 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.
An prospective double blinded randomised trial,whether the use of an perioperative echoguided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic.
Detailed description
Hernia inguinal repair is the most common operation performed by general surgeons in the Netherlands. On of the most common complications after hernia repair is postoperative and chronic pain. Postoperative pain is an expected but undesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return to full normal daily activities. There are indications that an insufficient treatment of postoperative pain is a risk factor for persistent or chronic pain after open inguinal hernia repair. Chronic pain is not uncommon after hernia repair, with an incidence of 11%.
The objective of this study is to determine, whether the use of an perioperative echo guided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic. There will be no further analysis in this study regarding the incidence of open hernia inguinal repair and chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Procedure: TAP block20 ml Levobupivacaine 0,5% |
| Local wound infiltration | Active comparator | Procedure: TAP block20 ml levobupivacaine 0,5% |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age between 18 and 80 year, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35.
Key exclusion criteria (1 listed)
- fever, a coagulation disorder, patients with kidney and liverfaillure, an infection at the place where the puncture place, preoperative use of narcotic and nonsteroidal antiinflammatory drugs.
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 |
|---|---|---|
| TAP block2 groups, group A a TAP block with 20 ml of Levobupivacaine 0,5% and subcutaneous wound infiltration with 20 ml sodium chloride (to blind patient and physician) and group B, TAP block with 20 ml sodium chloride and subcutaneous wound infiltration with 20 ml Levobupivacaine 0,5% (to blind patient and physician) | Procedure or surgery | Local wound infiltration, TAP block |
Primary outcome
Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation
Time frame: 48 hours
5 secondary outcomes
time to to first use of intravenous morfine
Time frame: 48 hours
the total amount of titrated postoperative morfine
Time frame: 48 hours
use of tramadol at home
Time frame: 48 hours
patient satisfaction
Time frame: 48 hours
the incidence of nausea and vomiting
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
Jens P Hering, Anesthesiologist principal investigator
Dijklander Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block in people with Hernia Inguinal, run by Dijklander Ziekenhuis at 1 site in Netherlands.
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: status not confirmed, as of the sponsor's last update on 15 Feb 2013. 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 Netherlands. 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?
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?
Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation (time frame: 48 hours). 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 15 Feb 2013.