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

August 25, 2023 updated by: Judith Andres, Hospital del Río Hortega

Analgesic Efficacy of Serratus Intercostal Block Versus Epidural Analgesia in Eventration Surgery : Prospective Observational 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Castilla Y León
      • Valladolid, Castilla Y León, Spain, 47008
        • Recruiting
        • Judith Andres
        • Contact:
          • María Teresa F Martín
          • Phone Number: 637571685

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

people undergoing to repair abdominal wall

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to Local anesthetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain management
Time Frame: 24h
Pain control. NRS scale at O,6, 12 and 24 h in postoperative time
24h
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
24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Río Hortega

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-EO132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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