EventrationPhase 4Analgesic StraNCT06014749
Serratus Intercostal Block Versus Epidural/Port Infiltration Analgesia in Eventration: Prospective Non Inferiority Study
A Phase 4 study testing undergo, ultrasound and Local anesthetic in people with Eventration and Regional Anesthesia, run by Hospital del Rio Hortega at 1 site in Spain.
Trial summary
Adequate pain control, rehabilitation and early postoperative recovery are currently the model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies, open and laparoscopic surgeries, both intraoperatively and postoperatively, one based on… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Eventration, Regional Anesthesia, Epidural; Anesthesia
- What is being tested?
- undergo, ultrasound and Local anesthetic
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 16 Feb 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abdominal eventration repair,
- over 18 years old,
- ASA I-III.
- Signature of the IC.
Who cannot join
- Allergy to Local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ANALGESIC STRATEGIES FOR ABDOMINAL WALL REPAIR: A RANDOMISED NON INFERIORITY TRIAL OF SIPB, EPIDURAL ANALGESIA, AND PORT INFILTRATION
Adequate pain control, rehabilitation and early postoperative recovery are currently the model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies, open and laparoscopic surgeries, both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions. or 3 port infiltration and 4 SIPB in laparoscopy We conducted an prospective non inferiority study with a low level of intervention. Epidural analgesia prior to general anesthesia and serratus-intercostal block prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC. in laparoscopic surgery both techiques are applied after induction of general anaesthesia
Read the detailed description
Adequate pain control, rehabilitation and early postoperative recovery are currently model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions. or 3 port infiltration and 4 SIPB in laparoscopy The investigators conducted an non inferiority study with a low level of intervention. Epidural analgesia , serratus-intercostal block and port infiltration prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC.
We will assess the analgesia provided by the techniques in both techniques and to compare the results.
- Being tested
- undergo, ultrasound, Local anesthetic
- Keywords
- Intercostal nerves, epidural,abdominal hernia
- Medical subject headings
- Gastroschisis, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
undergoProcedure or surgery
Also called Eventroplasty
regional anesthesia
ultrasoundDevice
Also called Regional anesthesia
ultrasound guided
Local anestheticDrug
Also called Regional anesthesia
local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Patient under serratus intercostal plane block | Active comparator | patients who will undergo a modified bilateral ultrasound-guided BRILMA block (SIPB) using a high-frequency linear probe (6-15 Hz) and 80 mm needle. Receives: Procedure: undergo; Device: ultrasound; Drug: Local anesthetic |
| patient under epidural analgesia | Active comparator | patients who undergo Epidural Analgesia prior to General Anesthesia and fentanyl 1 mcg/kg approx according to characteristics and needs and upon arrival at the URPA is connected to the PC Levobupi 0.125% at 6 ml / h + rescue boluses of Levobupi 0.125% 4 ml if needed in the 1st hours. Receives: Procedure: undergo; Drug: Local anesthetic |
| port infiltration | Active comparator | patients in the port infiltration group underwent local anaesthetic infiltration with 0.25% levobupivacaine at trocar sites, with the volume adjusted according to port number and size. Receives: Procedure: undergo; Drug: Local anesthetic |
| SIPB | Active comparator | SIPB group, an ultrasound-guided serratus intercostal plane block was performed after induction at the eighth rib level using 20 mL of 0.25% levobupivacaine. Receives: Procedure: undergo; Device: ultrasound; Drug: Local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain management
Pain control. NRS scale at O,6, 12 and 24 h in postoperative time
Measured: 24h
postoperative quality of recovery
Quality of recovery, QoR15 scale, that includes physical and psicological item. That scale will be fill by the patient 24 h after surgery
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Oct 2023
- Primary completion1 Jun 2024
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EventrationStudies 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Andres, Hospital del Rio Hortega
- Investigators
- María T Fernandez, MD, Study director, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014749
- Sponsor's protocol ID
- 22-EO132
- Acronym
- Analgesic Stra
- Status last verified
- Feb 2026
- First submitted
- 2 Aug 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: During the first year the preliminary results will be ready and will be present as abstract. Th estimated time to finish the study is 2 years
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALGESIC STRATEGIES FOR ABDOMINAL WALL REPAIR: A RANDOMISED NON INFERIORITY TRIAL OF SIPB, EPIDURAL ANALGESIA, AND PORT INFILTRATION
- ClinicalTrials.gov ID
- NCT06014749
- Acronym / sponsor ID
- Analgesic Stra / 22-EO132
- Keywords
- Intercostal nerves, epidural,abdominal hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 28 Aug 2023 (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.
Adequate pain control, rehabilitation and early postoperative recovery are currently the model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies, open and laparoscopic surgeries, both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions. or 3 port infiltration and 4 SIPB in laparoscopy We conducted an prospective non inferiority study with a low level of intervention. Epidural analgesia prior to general anesthesia and serratus-intercostal block prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC. in laparoscopic surgery both techiques are applied after induction of general anaesthesia
Detailed description
Adequate pain control, rehabilitation and early postoperative recovery are currently model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions. or 3 port infiltration and 4 SIPB in laparoscopy The investigators conducted an non inferiority study with a low level of intervention. Epidural analgesia , serratus-intercostal block and port infiltration prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC.
We will assess the analgesia provided by the techniques in both techniques and to compare the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient under serratus intercostal plane block | Active comparator | Procedure: undergo, Device: ultrasound, Drug: Local anestheticpatients who will undergo a modified bilateral ultrasound-guided BRILMA block (SIPB) using a high-frequency linear probe (6-15 Hz) and 80 mm needle. |
| patient under epidural analgesia | Active comparator | Procedure: undergo, Drug: Local anestheticpatients who undergo Epidural Analgesia prior to General Anesthesia and fentanyl 1 mcg/kg approx according to characteristics and needs and upon arrival at the URPA is connected to the PC Levobupi 0.125% at 6 ml / h + rescue boluses of Levobupi 0.125% 4 ml if needed in the 1st hours. |
| port infiltration | Active comparator | Procedure: undergo, Drug: Local anestheticpatients in the port infiltration group underwent local anaesthetic infiltration with 0.25% levobupivacaine at trocar sites, with the volume adjusted according to port number and size. |
| SIPB | Active comparator | Procedure: undergo, Device: ultrasound, Drug: Local anestheticSIPB group, an ultrasound-guided serratus intercostal plane block was performed after induction at the eighth rib level using 20 mL of 0.25% levobupivacaine. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- abdominal eventration repair,
- over 18 years old,
- ASA I-III.
- Signature of the IC.
Key exclusion criteria (1 listed)
- Allergy to Local anesthetic
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 |
|---|---|---|
| undergoAlso: Eventroplastyregional anesthesia | Procedure or surgery | Patient under serratus intercostal plane block, SIPB, patient under epidural analgesia, port infiltration |
| ultrasoundAlso: Regional anesthesiaultrasound guided | Device | Patient under serratus intercostal plane block, SIPB |
| Local anestheticAlso: Regional anesthesialocal anesthetic | Drug | Patient under serratus intercostal plane block, SIPB, patient under epidural analgesia, port infiltration |
Primary outcome
postoperative pain management
Time frame: 24h
Pain control. NRS scale at O,6, 12 and 24 h in postoperative time
postoperative quality of recovery
Time frame: 24h
Quality of recovery, QoR15 scale, that includes physical and psicological item. That scale will be fill by the patient 24 h 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 8 Jun 2026.
- Individual participant dataSharing planned: Undecided. During the first year the preliminary results will be ready and will be present as abstract. Th estimated time to finish the study is 2 years
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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.
María T Fernandez, MD study director
Hospital del Rio Hortega
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 undergo, ultrasound and Local anesthetic in people with Eventration and Regional Anesthesia, run by Hospital del Rio Hortega at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 8 Jun 2026. 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 Spain. 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?
postoperative pain management (time frame: 24h). The study lists 2 primary outcomes in all. 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 8 Jun 2026.