Ultrasound Guided Erector Spinae Plane Block

Ultrasound Guided Erector Spinae Plane Efficacy of Erector Spinae Plane Block for Analgesia in Breast Surgery

Patients were randomized into two groups, ESP and control. Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level was performed preoperatively to all patients in the ESP group. The control group received no intervention. Patients in both groups were provided with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.

Study Overview

• Status: Completed
• Conditions: Breast Diseases
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: Standart therapy

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmit
    • Kocaeli, Izmit, Turkey, 41100
      • Kocaeli Unıversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 18-65 age
2. Patients who scheduled for bilateral reduction mammoplasty
3. ASA Class I-II

Exclusion Criteria:

1. Coagulopaty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: erector spinae plane block group; Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level	Procedure: Erector Spinae Plane Block; Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine ( Marcaine ) at the T4 vertebral level will be performed.; Other Names: espb group
Active Comparator: control group; morphine pca to patient	Procedure: Standart therapy; Postoperative 0.5 mg/kg morphine and 1 gr paracetamol will be admistered intravenously in the operation theatre and intravenous patient controlled analgesia (PCA) will be performed in the plastic surgery ward postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	Patients in both groups will receive opioid in postoperative period. Total opioid consumption in miligrams will be compared	Postoperative total opioid consumption in miligrams will be recorded at hour 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative opioid consumption	The amount of remifentanyl administered to patients via intravenous infusion during the operation in micrograms, will be recorded.	At the end of the operation

Collaborators and Investigators

• Sponsor: Gözde Gamze Uzun

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: Kocaeli Univercity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No