Erector Spinae Plane Block for Postoperative Pain Management

NCT ID: NCT05697315

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-04-01

Brief 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.

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.

Conditions

Pain; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: PROCEDURE

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

Interventions

Control

No block was performed

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Gökçe Gişi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gökçe Gişi

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University Hospital Kahramanmaras, Turkey

Locations

Kahramanmaras Sutcu Imam University

Kahramanmaraş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021-02-03

Identifier Type: -

Identifier Source: org_study_id