Serratus Intercostal Block Versus Epidural/Port Infiltration Analgesia in Eventration: Prospective Non Inferiority Study (Analgesic Stra)

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

Study Overview

• Status: Completed
• Conditions: Abdominal Hernia; Regional Anesthesia; Epidural; Anesthesia; Eventration
• Intervention / Treatment: Procedure: undergo; Device: ultrasound; Drug: Local anesthetic

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 Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Spain
  • Castille and León
    • Valladolid, Castille and León, Spain, 47008
      • Judith Andres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

people undergoing to repair abdominal wall

Description

Inclusion Criteria:

• abdominal eventration repair,
• over 18 years old,
• ASA I-III.
• Signature of the IC.

Exclusion Criteria:

• Allergy to Local anesthetic

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient under serratus intercostal plane block; 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.	Procedure: undergo; regional anesthesia; Other Names: Eventroplasty; Device: ultrasound; ultrasound guided; Other Names: Regional anesthesia; Drug: Local anesthetic; local anesthetic; Other Names: Regional anesthesia
patient under epidural analgesia; 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.	Procedure: undergo; regional anesthesia; Other Names: Eventroplasty; Device: ultrasound; ultrasound guided; Other Names: Regional anesthesia; Drug: Local anesthetic; local anesthetic; Other Names: Regional anesthesia
port infiltration; 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.
SIPB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain management	Pain control. NRS scale at O,6, 12 and 24 h in postoperative time	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	24h

Collaborators and Investigators

• Sponsor: Hospital del Rio Hortega
• Investigators: Study Director: María T Fernandez, MD, Hospital del Rio Hortega

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): February 16, 2026

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Intercostal nerves, epidural,abdominal hernia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Musculoskeletal Abnormalities; Congenital Abnormalities; Hernia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Gastroschisis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Diagnostic Techniques and Procedures; Diagnosis; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Diagnostic Imaging; Anesthesia and Analgesia; Central Nervous System Agents; Anesthesia; Anesthetics, Local; Ultrasonography; Anesthesia, Conduction
• Other Study ID Numbers: 22-EO132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No