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Completed

NCT Number: NCT06657092

Ultrasound Guided Erector Spinae Plane Block

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.

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Key information

Conditions

Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli Unıversity

Kocaeli, izmit, 41100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-65 age
  • Patients who scheduled for bilateral reduction mammoplasty
  • ASA Class I-II

Exclusion criteria

  • Coagulopaty

Treatment and study plan

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.

Other names: espb 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

Primary outcomes

  1. Total opioid consumption

    Time frame: Postoperative total opioid consumption in miligrams will be recorded at hour 24

    Patients in both groups will receive opioid in postoperative period. Total opioid consumption in miligrams will be compared

Secondary outcomes

  1. Intraoperative opioid consumption

    Time frame: At the end of the operation

    The amount of remifentanyl administered to patients via intravenous infusion during the operation in micrograms, will be recorded.

Sponsors and collaborators

Lead sponsor

Gözde Gamze Uzun

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2024
Registry last updated
Oct 28, 2024

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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