Serratus Intercostal Block Versus Epidural Analgesia in Eventration: Prospective Observational Study

Completed

• Conditions: Abdominal Hernia; Regional Anesthesia; Epidural; Anesthesia; Eventration
• Interventions: Procedure: undergo; Device: ultrasound; Drug: Local anesthetic

• Registration Number: NCT06014749
• Lead Sponsor: Hospital del Rio Hortega

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 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.

We conducted an observational 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.

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.

The investigators conducted an observational 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.

We will assess the analgesia provided by both techniques and to compare the results.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-28
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• Allergy to Local anesthetic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient under serratus intercostal plane block	undergo	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.
patient under epidural analgesia	undergo	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.
Patient under serratus intercostal plane block	ultrasound	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.
patient under epidural analgesia	Local anesthetic	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.
Patient under serratus intercostal plane block	Local anesthetic	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.
patient under epidural analgesia	ultrasound	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.

Primary Outcome Measures

Name	Time	Method
postoperative pain management	24h	Pain control. NRS scale at O,6, 12 and 24 h in postoperative time
postoperative quality of recovery	24h	Quality of recovery, QoR15 scale, that includes physical and psicological item. That scale will be fill by the patient 24 h after surgery

Trial Locations

Locations (1)

Judith Andres; 🇪🇸 Valladolid, Castilla y León, Spain