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Completed

NCT Number: NCT06014749

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

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

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Key information

Conditions

Eventration Abdominal Hernia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epidural; Anesthesia Gastroschisis Hernia Hernia, Abdominal Musculoskeletal Abnormalities Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Regional Anesthesia

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Judith Andres

Valladolid, Castille and León, 47008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to Local anesthetic

Treatment and study plan

undergo

Procedure

regional anesthesia

Other names: Eventroplasty

Ultrasound

Device

ultrasound guided

Other names: Regional anesthesia

Local anesthetic

Drug

local anesthetic

Other names: Regional anesthesia

Primary outcomes

  1. postoperative pain management

    Time frame: 24h

    Pain control. NRS scale at O,6, 12 and 24 h in postoperative time

  2. 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

Sponsors and collaborators

Lead sponsor

Hospital del Rio Hortega

Other

Registry information

Official study title

ANALGESIC STRATEGIES FOR ABDOMINAL WALL REPAIR: A RANDOMISED NON INFERIORITY TRIAL OF SIPB, EPIDURAL ANALGESIA, AND PORT INFILTRATION

Acronym: Analgesic Stra

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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