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

NCT06014749 | Completed DMC FDA Drug FDA Device

• 1 other identifier: 22-EO132
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Eventration; Regional Anesthesia; Abdominal Hernia; Epidural; Anesthesia

Keywords

Intercostal nerves, epidural,abdominal hernia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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; Device: ultrasound; Drug: Local anesthetic

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; Device: ultrasound; Drug: Local anesthetic

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.

Interventions

ultrasound DEVICE

ultrasound guided

Also known as: Regional anesthesia

Patient under serratus intercostal plane block; patient under epidural analgesia

Local anesthetic DRUG

local anesthetic

Also known as: Regional anesthesia

Patient under serratus intercostal plane block; patient under epidural analgesia

undergo PROCEDURE

regional anesthesia

Also known as: Eventroplasty

Patient under serratus intercostal plane block; patient under epidural analgesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

people undergoing to repair abdominal wall

You may qualify if:

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

You may not qualify if:

• Allergy to Local anesthetic

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (1)

Judith Andres

Valladolid, Castille and León, 47008, Spain

Location

MeSH Terms

Conditions

Gastroschisis; Hernia, Abdominal

Interventions

Ultrasonography; Anesthesia, Conduction; Anesthetics, Local

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anesthesia; Anesthesia and Analgesia; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• María T Fernandez, MD

  Hospital del Rio Hortega

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 28, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: February 16, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

ES (1)