NCT06014749

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Hospital del Rio Hortega · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

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

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.

Conditions

• Eventration
• Regional Anesthesia
• Epidural; Anesthesia
• Abdominal Hernia

Interventions

Type	Name	Description
PROCEDURE	undergo	regional anesthesia
DEVICE	ultrasound	ultrasound guided
DRUG	Local anesthetic	local anesthetic

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-06-01
• Completion: 2026-02-16
• First posted: 2023-08-28
• Last updated: 2026-04-13

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study
• FDA-regulated device study