Inguinal HerniaNCT03128216
Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia
A study testing Blind Local Anesthetic infiltration, Transversals Fascia Block and Spinal Anesthesia in people with Inguinal Hernia, run by Istituti Ospitalieri di Cremona at 1 site in Italy.
Trial summary
Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Blind Local Anesthetic infiltration, Transversals Fascia Block and Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2017to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age> 18 years;
- ASA score I - II - III;
- patients undergoing elective inguinal hernia repair;
- signed informed consent;
Who cannot join
- chronic therapy with opioids/ antidepressants;
- urgent/emergent surgery;
- postoperative transfer to the intensive care unit;
- known allergy to any drug medication;
- local skin infection;
- epilepsy;
- alcohol or drug abuse;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Local Anesthetic Infiltration, Trasversalis Fascia Block or Spinal Anesthesia for Inguinal Hernia Repair
Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. The effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.
- Conditions
- Inguinal Hernia
- Being tested
- Blind Local Anesthetic infiltration, Transversals Fascia Block, Spinal Anesthesia, Ropivacaine, Bupivacaine
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blind Local Anesthetic infiltrationProcedure or surgery
Patients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon.
Transversals Fascia BlockProcedure or surgery
Patients of this group received ultrasound guided omolateral Transversals Fascia Block.
Spinal AnesthesiaProcedure or surgery
Patients of this group received Spinal Anesthesia
RopivacaineDrug
Local anesthetic used for local infiltration and Transversals fascia block
BupivacaineDrug
Local anesthetic used for Spinal Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Blind Local Anesthetic Infiltration | Active comparator | Not described Receives: Procedure: Blind Local Anesthetic infiltration; Drug: Ropivacaine |
| Transversals Fascia Block | Active comparator | Not described Receives: Procedure: Transversals Fascia Block; Drug: Ropivacaine |
| Spinal Anesthesia | Active comparator | Not described Receives: Procedure: Spinal Anesthesia; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital discharge
Time need to reach hospital discharge criteria in post-operative period
Measured: First 6 post-operative hours
Secondary outcomes (4)
Intraoperative Pain Control
Need of addiction local anesthetic or endovascular anesthetic to performed surgery
Measured: Intraoperative period
Post-operative Pain
NRS score in post-operative period
Measured: Post-operative period for 6 hours, every 30 min
Side effects
Incidence of side effects
Measured: intra-operative and post-operative period (6 hours)
Chronic Pain
Incidence of chronic post-operative pain
Measured: at 1 week and 3 months in post-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startApr 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Ospitalieri di Cremona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Basso Ricci, Istituti Ospitalieri di Cremona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128216
- Sponsor's protocol ID
- ANECR_02_17
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Local Anesthetic Infiltration, Trasversalis Fascia Block or Spinal Anesthesia for Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03128216
- Acronym / sponsor ID
- ANECR_02_17
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istituti Ospitalieri di CremonaUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 25 Apr 2017 (actual)
- 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.
Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. The effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blind Local Anesthetic Infiltration | Active comparator | Procedure: Blind Local Anesthetic infiltration, Drug: Ropivacaine |
| Transversals Fascia Block | Active comparator | Procedure: Transversals Fascia Block, Drug: Ropivacaine |
| Spinal Anesthesia | Active comparator | Procedure: Spinal Anesthesia, Drug: Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age> 18 years;
- ASA score I - II - III;
- patients undergoing elective inguinal hernia repair;
- signed informed consent;
Key exclusion criteria (7 listed)
- chronic therapy with opioids/ antidepressants;
- urgent/emergent surgery;
- postoperative transfer to the intensive care unit;
- known allergy to any drug medication;
- local skin infection;
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 |
|---|---|---|
| Blind Local Anesthetic infiltrationPatients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon. | Procedure or surgery | Blind Local Anesthetic Infiltration |
| Transversals Fascia BlockPatients of this group received ultrasound guided omolateral Transversals Fascia Block. | Procedure or surgery | Transversals Fascia Block |
| Spinal AnesthesiaPatients of this group received Spinal Anesthesia | Procedure or surgery | Spinal Anesthesia |
| RopivacaineLocal anesthetic used for local infiltration and Transversals fascia block | Drug | Blind Local Anesthetic Infiltration, Transversals Fascia Block |
| BupivacaineLocal anesthetic used for Spinal Anesthesia | Drug | Spinal Anesthesia |
Primary outcome
Hospital discharge
Time frame: First 6 post-operative hours
Time need to reach hospital discharge criteria in post-operative period
4 secondary outcomes
Intraoperative Pain Control
Time frame: Intraoperative period
Post-operative Pain
Time frame: Post-operative period for 6 hours, every 30 min
Side effects
Time frame: intra-operative and post-operative period (6 hours)
Chronic Pain
Time frame: at 1 week and 3 months in post-operative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blind Local Anesthetic infiltration, Transversals Fascia Block and Spinal Anesthesia in people with Inguinal Hernia, run by Istituti Ospitalieri di Cremona at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. 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 Italy. 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?
Contact Erika Basso Ricci, M.D. (+3903724050, e.bassoricci@asst-cremona.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital discharge (time frame: First 6 post-operative 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 25 Apr 2017.