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NCT Number: NCT05697315

Erector Spinae Plane Block for Postoperative Pain Management

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.

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Key information

Conditions

Pain Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Procedure

No block was performed

Erector Spinae Plane Block

Procedure

Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2023
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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