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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06014749
Acronym
Analgesic Stra
Enrollment
160
Registered
2023-08-28
Start date
2023-10-01
Completion date
2026-02-16
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Hernia, Epidural; Anesthesia, Eventration, Regional Anesthesia

Keywords

Intercostal nerves, epidural,abdominal hernia

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

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.

Interventions

PROCEDUREundergo

regional anesthesia

DEVICEultrasound

ultrasound guided

DRUGLocal anesthetic

local anesthetic

Sponsors

Hospital del Rio Hortega
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Allergy to Local anesthetic

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain management24hPain control. NRS scale at O,6, 12 and 24 h in postoperative time
postoperative quality of recovery24hQuality of recovery, QoR15 scale, that includes physical and psicological item. That scale will be fill by the patient 24 h after surgery

Countries

Spain

Contacts

STUDY_DIRECTORMaría T Fernandez, MD

Hospital del Rio Hortega

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026