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Completed

NCT Number: NCT04689581

Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery

In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery.

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Key information

Conditions

Postoperative Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, Turkey (Türkiye)

About this study

After being informed about the study and potential risks, written consent was obtained from all patients. Patients who meet eligibility requirements will be randomized in a 1:1 ratio to bi- level erector spinae plane block and modified pectoral block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists Classification (ASA) I-II patients
  • 18-70 aged patients
  • patients who scheuled elective breast cancer surgery

Exclusion criteria

  • American Society of Anesthesiologists Classification (ASA) III-IV patients
  • patients with coagulopathy
  • patients with infection at the injection site

Treatment and study plan

Ultrasound guided bi-level erector spinae plane block

Other

Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.

Ultrasound guided modified pectoral nerve block

Other

Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.

Primary outcomes

  1. Morphin consumption

    Time frame: during postoperative 24 hour

    Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.

  2. numerical rating scale (NRS)

    Time frame: during postoperative 24 hour

    A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Comparison of Postoperative Efficacy of Ultrasound-guided Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Cancer Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2020
Registry last updated
Jun 29, 2021

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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