A Phase 4 interventional study of undergo and ultrasound in Eventration, Regional Anesthesia and Epidural; Anesthesia, sponsored by Hospital del Rio Hortega. Completed at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Hospital del Rio Hortega · Phase 4, Interventional, and Treatment
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
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.
42 studies on the registry are indexed under Gastroschisis; 6 are open to participants now.
This study's enrollment of 160 is above the median of 44 across 26 interventional studies indexed under Gastroschisis.
Browse Gastroschisis studies →Hospital del Rio Hortega is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 · Drug: Local anesthetic
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.
Procedure: undergo · Drug: Local anesthetic
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.
Procedure: undergo · Device: ultrasound · Drug: Local anesthetic
regional anesthesia
Also known as: Eventroplasty
ultrasound guided
Also known as: Regional anesthesia
local anesthetic
Also known as: Regional anesthesia
postoperative pain management
Pain control. NRS scale at O,6, 12 and 24 h in postoperative time
Time frame: 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
Time frame: 24h
Plan to share: Undecided — During the first year the preliminary results will be ready and will be present as abstract. Th estimated time to finish the study is 2 years
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Hospital del Rio Hortega