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NCT Number: NCT03621345

Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery

Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. So, the investigators believed that the ESP block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.

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Key information

Conditions

Postoperative Pain Breast Hypertrophy Gigantomastia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Sariçam, 01100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery

Exclusion criteria

  • Coagulopathy
  • Allergy to amide-type local anesthetics
  • Infection at the ESP block injection site
  • Severe obesity (BMI > 35 kg/m2)
  • Liver or renal deficiency
  • Patients with anatomical deformities
  • Recent use of analgesic drugs
  • Patient refusal or inability to consent

Treatment and study plan

Erector Spinae Plane Block

Procedure

Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.

sham block

Other

A sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients.

Primary outcomes

  1. Postoperative morphine consumption

    Time frame: 24 hours

    Morphine consumption in Patient Controlled Analgesia device

Secondary outcomes

  1. Intraoperative anesthetic consumption

    Time frame: During operation time

    Intraoperative total doses of remifentanil, pentothal, desflurane consumption

  2. Extubation and recovery time

    Time frame: Through surgical operation completion

    Using modified aldrete score

  3. Pain assessed by NRS

    Time frame: 24 hours

    Numeric rating scale (NRS) at rest and in motion will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  4. Degree of sedation

    Time frame: 24 hours

    Ramsay Sedation Scale (RSS) will be used to assess degree of sedation. The RSS was designed as a test of arousability. The RSS scores sedation at six different levels, according to how arousable the patient is. The RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive.

  5. Rate of opioid related side effects

    Time frame: 24 hours

    Opioid related side effects such as nause/vomiting, pruritis, bradycardia, hypotension will be evaluated at intervals up to 24 hours.

  6. Supplemental and rescue analgesic requirement

    Time frame: 24 hours

    Total supplemental and rescue analgesic consumption

  7. Patient satisfaction assessment

    Time frame: At the postoperative 24th hour

    It will be assessed with patient satisfaction scale classified as 'excellent': no pain, NRS=0; 'good': very mild pain, NRS=1-2; 'moderate': mild pain, NRS=3-4.

  8. Bilateral shoulder mobility

    Time frame: Preoperative and postoperative 4th, 8th, 12th, and 24th hours

    It will be assessed with ability of shoulder abduction degree

  9. Length of stay in hospital

    Time frame: Until discharge from hospital, up to 7 days postoperatively

    Duration of length of stay in hospital will be recorded

  10. Rate of block related complications

    Time frame: Until discharge from hospital, up to 7 days postoperatively

    Rate of block related complications such as hematoma, nerve deficit, pneumothorax etc. will be recoded.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2018
Registry last updated
Feb 10, 2023

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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