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

Regional Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014749
• Other study ID #: 22-EO132
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Hospital del Río Hortega
• Contact: judith Andres, MD
• Phone: +34661633123
• Email: jandressa[@]saludcastillayleon.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Allergy to Local anesthetic

Related Conditions & MeSH terms

• Abdominal Hernia
• Epidural; Anesthesia
• Eventration
• Gastroschisis
• Hernia
• Hernia, Abdominal
• Hernia, Umbilical
• Internal Hernia
• Regional Anesthesia

Intervention

Procedure:
• undergo
regional anesthesia

Device:
• ultrasound
ultrasound guided

Drug:
• Local anesthetic
local anesthetic

Locations

Country	Name	City	State
Spain	Judith Andres	Valladolid	Castilla Y León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Río Hortega

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain management	Pain control. NRS scale at O,6, 12 and 24 h in postoperative time	24h
Primary	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	24h