HerniaPhase 4NCT01052285

The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

A Phase 4 study testing Transversus abdominis plane block, Saline and Local infiltration in people with Hernia, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hernia
What is being tested?: Transversus abdominis plane block, Saline and Local infiltration
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteDenmark
Study dates: Jun 2010to Nov 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-75 years old
groin hernia repair
written consent
ASA 1-3
BMI 18-35

Who cannot join

unable to communicate in Danish
relevant drug allergy
pain medication in the last 24 hours
pregnancy
alcohol or/and drug abuse
daily opioid intake
infection at injection site

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of Anaesthesiology, Glostrup university hospital
Glostrup Municipality, 2600

Other trials in Denmark

About this study

Official title: The Efficacy of Transversus Abdominis Plane Block Versus Placebo Versus Local Infiltration in Patients Undergoing Groin Hernia Repair in Day Case Surgery.

The purpose of this study is to determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair.

Conditions: Hernia
Being tested: Transversus abdominis plane block, Saline, Local infiltration
Keywords: Transversus abdominis plane block
Medical subject headings: Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transversus abdominis plane blockProcedure or surgery
Also called postoperative pain, UL-guided block
UL-guided TAP block with 25 ml of ropivacaine 0,75% unilateral, single dose, ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline
SalineProcedure or surgery
Also called postoperative pain.
UL-guided Tap block with 25 ml of saline single dose Ilioinguinal block with 10 ml of saline and local infiltration with saline 40 ml single dose
Local infiltrationProcedure or surgery
Also called Local wound infiltration
Ilioinguinal block with 10 ml of ropivacaine 0,375% single dose, local infiltration with 40 ml of ropivacaine 0,375% single dose, UL-guided Tap block with 25 ml of saline single dose

Study groups in NCT01052285
Study group	Role	What they receive
Placebo	Placebo comparator	TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline. Receives: Procedure: Saline
Local infiltration	Active comparator	Ilioinguinal block with 10 ml of ropivacaine 0,375% Local infiltration with 40 ml of ropivacaine 0,375% Tap block with 25 ml of saline Receives: Procedure: Local infiltration
Transversus abdominis plane block	Experimental	25 ml of Ropivacaine 0,75%, Ilioinguinal block with 10 ml saline and local infiltration with 40 ml of saline. Receives: Procedure: Transversus abdominis plane block

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain scores by coughing between TAP block group and placebo group
Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,19,24 hours postoperative
Measured: 0,2,4,6,8,19 and 24 hours postoperative

Secondary outcomes (5)

Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.
Area under the curve (AUC)-pain during cough based on measurements 0,2,4,6,8,19,24 hours postoperative.
Measured: 0,2,4,6,8,19 and 24 hours postoperative
Total opioid consumption
Total morphine consumption 0-2 hours postoperative. Total ketobemidone consumption 2-24 hours postoperative.
Measured: 0-24 hours postoperative
Postoperative nausea and vomiting
Levels of nausea (0-3)at 0,2,4,6,8,19,24 hours postoperative Number of vomits 0-2, 2-4, 4-6, 6-8, 8-19 og 19-24 hours postoperative.
Measured: 0,2,4,6,8,19,24 hours postoperative
Sedation
Levels of sedation (0-3)at 0,2,4,6,8,19,24 hours postoperative.
Measured: 0,2,4,6,8,19,24 hours postoperative
Pain scores at rest between TAP block versus placebo and TAP block versus infiltration and infiltration versus placebo
Area under the curve (AUC)-pain at rest based on measurements at 0,2,4,6,8,19,24 hours postoperative
Measured: 0,2,4,6,8,19,24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Nov 2011

First posted20 Jan 2010 (estimated)
Study startJun 2010
Primary completionNov 2011
Study completionNov 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 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: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01052285
Sponsor's protocol ID: SM1-plp-10
Other IDs: 2010-018403-29
Status last verified: Nov 2011
First submitted: 19 Jan 2010
Last updated: 18 Nov 2011
Results posted: No
Data monitoring committee: Yes

Publications

Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.
PubMed 23549122

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia

All Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Transversus Abdominis Plane Block Versus Placebo Versus Local Infiltration in Patients Undergoing Groin Hernia Repair in Day Case Surgery.
ClinicalTrials.gov ID: NCT01052285
Acronym / sponsor ID: SM1-plp-10
Conditions: Hernia
Keywords: Transversus abdominis plane block
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Glostrup University Hospital, CopenhagenUniversity, hospital or other
Study start: Jun 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 20 Jan 2010 (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.

The purpose of this study is to determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin 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: 3

Arm	Type	Receives
Placebo	Placebo comparator	Procedure: SalineTAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline.
Local infiltration	Active comparator	Procedure: Local infiltrationIlioinguinal block with 10 ml of ropivacaine 0,375% Local infiltration with 40 ml of ropivacaine 0,375% Tap block with 25 ml of saline
Transversus abdominis plane block	Experimental	Procedure: Transversus abdominis plane block25 ml of Ropivacaine 0,75%, Ilioinguinal block with 10 ml saline and local infiltration with 40 ml of saline.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18-75 years old
groin hernia repair
written consent
ASA 1-3
BMI 18-35

Key exclusion criteria (7 listed)

unable to communicate in Danish
relevant drug allergy
pain medication in the last 24 hours
pregnancy
alcohol or/and drug abuse

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
Transversus abdominis plane blockAlso: postoperative pain, UL-guided blockUL-guided TAP block with 25 ml of ropivacaine 0,75% unilateral, single dose, ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline	Procedure or surgery	Transversus abdominis plane block
SalineAlso: postoperative pain.UL-guided Tap block with 25 ml of saline single dose Ilioinguinal block with 10 ml of saline and local infiltration with saline 40 ml single dose	Procedure or surgery	Placebo
Local infiltrationAlso: Local wound infiltrationIlioinguinal block with 10 ml of ropivacaine 0,375% single dose, local infiltration with 40 ml of ropivacaine 0,375% single dose, UL-guided Tap block with 25 ml of saline single dose	Procedure or surgery	Local infiltration

Primary outcome

Pain scores by coughing between TAP block group and placebo group
Time frame: 0,2,4,6,8,19 and 24 hours postoperative
Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,19,24 hours postoperative

5 secondary outcomes

Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.
Time frame: 0,2,4,6,8,19 and 24 hours postoperative
Total opioid consumption
Time frame: 0-24 hours postoperative
Postoperative nausea and vomiting
Time frame: 0,2,4,6,8,19,24 hours postoperative
Sedation
Time frame: 0,2,4,6,8,19,24 hours postoperative
Pain scores at rest between TAP block versus placebo and TAP block versus infiltration and infiltration versus placebo
Time frame: 0,2,4,6,8,19,24 hours postoperative

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 18 Nov 2011.
Derived from this study: PubMed 23549122Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.

Related trials for Hernia

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia

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.

Pernille L Petersen, MD principal investigator

Glostrup University Hospital

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 Transversus abdominis plane block, Saline and Local infiltration in people with Hernia, run by Glostrup University Hospital, Copenhagen 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 5 inclusion and 7 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 18 Nov 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?

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?

Pain scores by coughing between TAP block group and placebo group (time frame: 0,2,4,6,8,19 and 24 hours postoperative). 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 NCT01052285, 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 18 Nov 2011.