Ultrasound Guided Erector Spinae Plane Block

NCT06657092 | Completed

• 1 other identifier: Kocaeli Univercity
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intraoperative opioid consumption

  At the end of the operation

Study Arms (2)

erector spinae plane block group

ACTIVE COMPARATOR

Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level

Procedure: Erector Spinae Plane Block

control group

ACTIVE COMPARATOR

morphine pca to patient

Procedure: Standart therapy

Interventions

Erector Spinae Plane Block PROCEDURE

Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine ( Marcaine ) at the T4 vertebral level will be performed.

Also known as: espb group

erector spinae plane block group

Standart therapy PROCEDURE

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

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age
• Patients who scheduled for bilateral reduction mammoplasty
• ASA Class I-II

You may not qualify if:

• \. Coagulopaty

Sponsors & Collaborators

• Gözde Gamze Uzun: lead

Study Sites (1)

Kocaeli Unıversity

Kocaeli, izmit, 41100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Model Details: Patients were randomized into two groups, ESPB and control.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: October 24, 2024
• Study Start: March 4, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 30, 2022
• Last Updated: October 28, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)