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

Sponsor
Hospital del Río Hortega (Other)
Overall Status
Recruiting
CT.gov ID
NCT06014749
Collaborator
(none)
80
1
28
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: undergo
  • Device: ultrasound
  • Drug: Local anesthetic

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Analgesic Efficacy of Serratus Intercostal Block Versus Epidural Analgesia in Eventration Surgery : Prospective Observational Study
Actual Study Start Date :
Sep 1, 2022
Actual Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Patient under serratus intercostal plane block

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
regional anesthesia
Other Names:
  • Eventroplasty
  • Device: ultrasound
    ultrasound guided
    Other Names:
  • Regional anesthesia
  • Drug: Local anesthetic
    local anesthetic
    Other Names:
  • Regional anesthesia
  • patient under epidural analgesia

    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
    regional anesthesia
    Other Names:
  • Eventroplasty
  • Device: ultrasound
    ultrasound guided
    Other Names:
  • Regional anesthesia
  • Drug: Local anesthetic
    local anesthetic
    Other Names:
  • Regional anesthesia
  • Outcome Measures

    Primary Outcome Measures

    1. postoperative pain management [24h]

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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • abdominal eventration repair,

    • over 18 years old,

    • ASA I-III.

    • Signature of the IC.

    Exclusion Criteria:
    • Allergy to Local anesthetic

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Judith Andres Valladolid Castilla Y León Spain 47008

    Sponsors and Collaborators

    • Hospital del Río Hortega

    Investigators

    • Study Director: María T Fernandez, MD, Hospital del Río Hortega

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Judith Andres, MD, Hospital del Río Hortega
    ClinicalTrials.gov Identifier:
    NCT06014749
    Other Study ID Numbers:
    • 22-EO132
    First Posted:
    Aug 28, 2023
    Last Update Posted:
    Aug 28, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Judith Andres, MD, Hospital del Río Hortega
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 28, 2023