Erector Spinae Plane Block for Postoperative Pain Management

January 16, 2023 updated by: Gökçe Gişi, Kahramanmaras Sutcu Imam University

The Effect of Erector Spinae Block for Postoperative Pain Management Cesarean Delivery Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey, 46100
        • Kahramanmaraş Sütçü İmam University

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Procedure: Control
No block was performed
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

Collaborators and Investigators

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

Sponsor

Kahramanmaras Sutcu Imam University

Investigators

  • Principal Investigator: Gökçe Gişi, Kahramanmaras Sutcu Imam University Hospital Kahramanmaras, Turkey

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)

December 1, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Estimate)

January 25, 2023

Study Record Updates

Last Update Posted (Estimate)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-02-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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