Erector Spinae Plane Block for Postoperative Pain Management

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697315
• Other study ID #: 2021-02-03
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2023
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Control
No block was performed
• 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.

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour opioid consumption	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	Visual Analog Scale (Vas)	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