Inguinal HerniaNCT02030223
Transversus Abdominis Plane Block and Inguinal Hernia Repair
A study testing Transversus abdominis plane block in people with Inguinal Hernia and Abdominal Wall Muscles, run by Papacharalampous Panagiota at 1 site in Greece.
Trial summary
This prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia, Abdominal Wall Muscles, Regional Anesthesia
- What is being tested?
- Transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2014to Dec 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III patients undergoing inguinal hernia repair with a mesh
- age between 18 and 75 years old
- ability to read and write greek
- -
Who cannot join
- Inability to consent to the study
- BMI >40kg/m2
- Skin infection at the puncture site
- Contraindication to mono-amide local anaesthetics, paracetamol, NSAID's (parecoxib)
- Preoperative use of opioids or NSAID's for chronic pain conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Efficacy of the Ultrasound Guided Transversus Abdominis Plane Block After Inguinal Hernia Repair With a Mesh.
This prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how the efficiency of early postoperative analgesia achieved correlates with the risk of developing a chronic pain state, a not uncommon condition after this type of surgery.
- Being tested
- Transversus abdominis plane block
- Keywords
- transversus abdominis plane block, inguinal hernia repair, acute postoperative pain, neuropathic pain
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative, Neuralgia
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
ultrasound guided transversus abdominis plane block
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdominis plane block with 20 ml ropivacaine 0,75% | Active comparator | Transversus abdominis plane block with 20 ml ropivacaine 0,75% Receives: Procedure: Transversus abdominis plane block |
| Transversus abdominis plane block with 20 ml saline | Placebo comparator | Transversus abdominis plane block with 20 ml 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 at rest and with movement using the numerical rating scale (NRS)
Measured: 3, 6 and 24 hours postoperatively
Secondary outcomes (1)
Incidence of chronic pain
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papacharalampous Panagiota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Papacharalampous Panagiota, Aretaieion University Hospital
- Investigators
- Erifyli Argyra, MD, PhD, Study chair, Aretaieion University HospitalKassiani Theodoraki, MD, PhD, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030223
- Sponsor's protocol ID
- PAM-2345-1786
- Status last verified
- Feb 2018
- First submitted
- 7 Jan 2014
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16.
PubMed 23160979Petersen 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of the Ultrasound Guided Transversus Abdominis Plane Block After Inguinal Hernia Repair With a Mesh.
- ClinicalTrials.gov ID
- NCT02030223
- Acronym / sponsor ID
- PAM-2345-1786
- Keywords
- transversus abdominis plane block, inguinal hernia repair, acute postoperative pain, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Papacharalampous PanagiotaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Jan 2014 (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 prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how the efficiency of early postoperative analgesia achieved correlates with the risk of developing a chronic pain state, a not uncommon condition after this type of surgery.
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 |
|---|---|---|
| Transversus abdominis plane block with 20 ml ropivacaine 0,75% | Active comparator | Procedure: Transversus abdominis plane blockTransversus abdominis plane block with 20 ml ropivacaine 0,75% |
| Transversus abdominis plane block with 20 ml saline | Placebo comparator | Procedure: Transversus abdominis plane blockTransversus abdominis plane block with 20 ml saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III patients undergoing inguinal hernia repair with a mesh
- age between 18 and 75 years old
- ability to read and write greek
- -
Key exclusion criteria (5 listed)
- Inability to consent to the study
- BMI >40kg/m2
- Skin infection at the puncture site
- Contraindication to mono-amide local anaesthetics, paracetamol, NSAID's (parecoxib)
- Preoperative use of opioids or NSAID's for chronic pain conditions
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 blockultrasound guided transversus abdominis plane block | Procedure or surgery | Transversus abdominis plane block with 20 ml ropivacaine 0,75%, Transversus abdominis plane block with 20 ml saline |
Primary outcome
Pain scores at rest and with movement using the numerical rating scale (NRS)
Time frame: 3, 6 and 24 hours postoperatively
1 secondary outcome
Incidence of chronic pain
Time frame: 6 months after surgery
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 19 Feb 2018.
- Results publication: PubMed 23160979Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16.
- Results publication: 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.
- THE JOURNAL OF THE NEW YORK SCHOOL OF REGIONAL ANESTHESIALink provided by the sponsor.
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Erifyli Argyra, MD, PhD study chair
Aretaieion University Hospital
Kassiani Theodoraki, MD, PhD principal investigator
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block in people with Inguinal Hernia and Abdominal Wall Muscles, run by Papacharalampous Panagiota at 1 site in Greece.
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 5 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 19 Feb 2018. 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 Greece. 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.
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 at rest and with movement using the numerical rating scale (NRS) (time frame: 3, 6 and 24 hours postoperatively). 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 NCT02030223, which also lists 2 linked publications.
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 19 Feb 2018.