Inguinal HerniaPhase 4U-IFBNCT01521481
Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery
A Phase 4 study testing Triple inguinal nerve block. and Unilateral subarachnoid anesthesia in people with Inguinal Hernia, run by Azienda Ospedaliera San Gerardo di Monza at 1 site in Italy.
Trial summary
The purpose of this study is to investigate the analgesic efficacy of an ultrasound-guided inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve). Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Triple inguinal nerve block. and Unilateral subarachnoid anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to Feb 2012
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI (Body mass index) < 30
- Non severe liver, renal or cardiac disease
- No allergy or contraindications to any of the study drugs
- American Hernia Society Score type I-II-IV-V hernia
- No pain or chronic analgesic administration in the preoperative period
- No previous surgery of the inguinal region
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- Normal coagulation parameters and platelet count (> 100.000).
- Dicumarol and aspirin suspension for > 7 days
- Correctly administrated premedication
- No systemic infections
- No contraindications to subarachnoid anesthesia
Who cannot join
- BMI (Body mass index) > 30
- Severe liver, renal or cardiac disease
- Allergy or contraindications to any of the study drugs
- American Hernia Society Score type III-VI-VII-0 hernia
- Pain or chronic analgesic administration in the preoperative period
- Previous surgery of the inguinal region
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- Anormal coagulation parameters and platelet count (< 100.000).
- No dicumarol and aspirin suspension for > 7 days
- Incorrectly administrated premedication
- Systemic infections
- Contraindications to subarachnoid anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery.
The purpose of this study is to investigate the analgesic efficacy of an ultrasound-guided inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve).
Read the detailed description
Inguinal hernia repair accounts for 10-15% of all operations in general surgery. Moderate to severe pain can occur at the first day after inguinal hernia repair in 25% of patients at rest and in 60% during activity. On day 6 after the operation the incidence can be as high as 11% at rest and 33% during activity.
Ultrasound imaging for regional anesthesia techniques have improved the success and safety rate of nerve blocks. We hypothesized that a procedure consisting of an ultrasound-guided inguinal field block (genitofemoral, iliohypogastric and ilioinguinal nerve block and incision line infiltration) could effectively control postoperative pain compared to selective unilateral subarachnoid anesthesia.
- Conditions
- Inguinal Hernia
- Being tested
- Triple inguinal nerve block., Unilateral subarachnoid anesthesia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple inguinal nerve block.Other
Also called Regional anesthesia for the groin.
Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
Unilateral subarachnoid anesthesiaOther
Also called Regional anesthesia for the groin.
Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
| Study group | Role | What they receive |
|---|---|---|
| Triple inguinal nerve block | Experimental | Ropivacaine 5 mg/ml Receives: Other: Triple inguinal nerve block. |
| Unilateral subarachnoid anesthesia | Active comparator | Bupivacaine 10 mg/ml Receives: Other: Unilateral subarachnoid anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity.
Postoperative pain will be assessed by numeric ranking scale (numeric ranking scale NRS 0 to 10 points) at rest (static numeric ranking scale NRS) and during activity (dynamic numeric ranking scale NRS).
Measured: Up to 24 hours.
Secondary outcomes (9)
Supplemental local anesthesia infiltration
If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.
Measured: During surgery, up to 2 hours.
Conversion to general anesthesia.
Patients will receive remifentanil adjusted to maintain spontaneous breathing and conscious sedation with a Ramsay score = 2 during surgery if modest pain (numeric ranking scale NRS > 4 and agitation) is sustained. If remifentanil is not sufficient for restoring patient comfort, the block will be considered failed and the patient will be given general anesthesia with propofol and a Proseal Laryngeal Mask.
Measured: During surgery, up to 2 hours
mPADSS (Post-Anesthesia Discharge Scoring System)
Assessed at every evaluation time postoperatively. The modified Post-Anesthesia Discharge Scoring System (mPADSS) includes stable heart and respiratory rates, absence of excessive nausea and pain, no bleeding from the surgical site, and ability to walk without support.
Measured: Up to 24 hours
Analgesic requirement
Assessed at every evaluation time postoperatively.
Measured: Up to 7 days
Activity
Assessed through the activities assessment questionnaire 7 days after surgery.
Measured: Up to 7 days
Adverse events.
Assessed at every evaluation time and including surgical and anesthesiological related events.
Measured: Up to 7 days
Time from the end of anesthesia to first micturition.
Assessed at every evaluation time postoperatively.
Measured: Up to 24 hours.
Time from the end of surgery to the first unassisted walking.
Assessed at every evaluation time postoperatively.
Measured: Up to 24 hours.
Total intrahospital stay.
Assessed at every evaluation time postoperatively.
Measured: Up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionFeb 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Gerardo di Monza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhirajr Mokini M.D., Azienda Ospedaliera San Gerardo di Monza
- Investigators
- Zhirajr Mokini, M.D., Principal investigator, San Gerardo HospitalPablo Mauricio Ingelmo, M.D., Study director, San Gerardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521481
- Sponsor's protocol ID
- AR HSG 03 2010
- Acronym
- U-IFB
- Status last verified
- Feb 2014
- First submitted
- 24 Jan 2012
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery.
- ClinicalTrials.gov ID
- NCT01521481
- Acronym / sponsor ID
- U-IFB / AR HSG 03 2010
- Conditions
- Inguinal Hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Jan 2012 (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 investigate the analgesic efficacy of an ultrasound-guided inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve).
Detailed description
Inguinal hernia repair accounts for 10-15% of all operations in general surgery. Moderate to severe pain can occur at the first day after inguinal hernia repair in 25% of patients at rest and in 60% during activity. On day 6 after the operation the incidence can be as high as 11% at rest and 33% during activity.
Ultrasound imaging for regional anesthesia techniques have improved the success and safety rate of nerve blocks. We hypothesized that a procedure consisting of an ultrasound-guided inguinal field block (genitofemoral, iliohypogastric and ilioinguinal nerve block and incision line infiltration) could effectively control postoperative pain compared to selective unilateral subarachnoid anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple inguinal nerve block | Experimental | Other: Triple inguinal nerve block.Ropivacaine 5 mg/ml |
| Unilateral subarachnoid anesthesia | Active comparator | Other: Unilateral subarachnoid anesthesiaBupivacaine 10 mg/ml |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- BMI (Body mass index) < 30
- Non severe liver, renal or cardiac disease
- No allergy or contraindications to any of the study drugs
- American Hernia Society Score type I-II-IV-V hernia
- No pain or chronic analgesic administration in the preoperative period
Key exclusion criteria (11 listed)
- BMI (Body mass index) > 30
- Severe liver, renal or cardiac disease
- Allergy or contraindications to any of the study drugs
- American Hernia Society Score type III-VI-VII-0 hernia
- Pain or chronic analgesic administration in the preoperative period
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 |
|---|---|---|
| Triple inguinal nerve block.Also: Regional anesthesia for the groin.Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg. | Other | Triple inguinal nerve block |
| Unilateral subarachnoid anesthesiaAlso: Regional anesthesia for the groin.Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia. | Other | Unilateral subarachnoid anesthesia |
Primary outcome
Pain Intensity.
Time frame: Up to 24 hours.
Postoperative pain will be assessed by numeric ranking scale (numeric ranking scale NRS 0 to 10 points) at rest (static numeric ranking scale NRS) and during activity (dynamic numeric ranking scale NRS).
9 secondary outcomes
Supplemental local anesthesia infiltration
Time frame: During surgery, up to 2 hours.
Conversion to general anesthesia.
Time frame: During surgery, up to 2 hours
mPADSS (Post-Anesthesia Discharge Scoring System)
Time frame: Up to 24 hours
Analgesic requirement
Time frame: Up to 7 days
Activity
Time frame: Up to 7 days
Adverse events.
Time frame: Up to 7 days
Time from the end of anesthesia to first micturition.
Time frame: Up to 24 hours.
Time from the end of surgery to the first unassisted walking.
Time frame: Up to 24 hours.
Total intrahospital stay.
Time frame: Up to 24 hours.
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 4 Feb 2014.
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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.
Zhirajr Mokini, M.D. principal investigator
San Gerardo Hospital
Pablo Mauricio Ingelmo, M.D. study director
San Gerardo 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 Triple inguinal nerve block. and Unilateral subarachnoid anesthesia in people with Inguinal Hernia, run by Azienda Ospedaliera San Gerardo di Monza 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 11 inclusion and 11 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 4 Feb 2014. 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.
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 Intensity. (time frame: Up to 24 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 4 Feb 2014.