Erector Spinae Plane Block for Postoperative Pain Management

Overview

Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block after cesarean section (CS) with Pfannenstiel incision under spinal anesthesia.

Full Title of Study: “The Effect of Erector Spinae Block for Postoperative Pain Management Cesarean Delivery Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 1, 2022

Detailed Description

The study included 54 patients with mild systemic disease (ASA II patients) who would undergo elective CS under spinal anesthesia. They were randomly divided into an ESP block group (Group E) and a control group (Group C). After the surgery, Group E patients underwent ultrasound-guided bilateral ESP block with 20 ml of 0.25% bupivacaine at the lateral decubitus position, while Group C received no intervention. Patients in both groups received parenteral patient-controlled analgesia. The patients' post-operative 24-hour opioid consumption, regular Visual Analogue Scale (VAS) measurements, and need for rescue analgesics were evaluated. Statistical analysis was performed using SPSS 21 program. Demographic and other data were assessed using independent samples t-test, Mann-Whitney U test, and Chi-square analysis.

Interventions

  • Procedure: Control
    • No block was performed
  • Procedure: Erector spinae plane block
    • Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Arms, Groups and Cohorts

  • Sham Comparator: Control group
    • No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
  • Active Comparator: Erector spinae plane block
    • Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Clinical Trial Outcome Measures

Primary Measures

  • 24-hour opioid consumption
    • Time Frame: up to 24 hour
    • The amount of tramadol consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.

Secondary Measures

  • Visual Analog Scale (Vas)
    • Time Frame: 0, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
    • pain scores,graded from 0 to 10, 0 no pain, 10 highest pain experienced

Participating in This Clinical Trial

Inclusion Criteria

  • ASA II patients – 18-45 years who underwent CS with Pfannenstiel incision under spinal anesthesia – agreed to participate in the study Exclusion Criteria:

  • Patients with infection at the injection site – Coagulopathy Allergy to amide-type local anesthetics – History of peripheral neuropathy – Hepatic and/or renal failure – Refusing the procedure – patients with heart disease

Gender Eligibility: Female

Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kahramanmaras Sutcu Imam University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gökçe Gişi, Assistant Professor – Kahramanmaras Sutcu Imam University
  • Overall Official(s)
    • Gökçe Gişi, Principal Investigator, Kahramanmaras Sutcu Imam University Hospital Kahramanmaras, Turkey

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