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

Overview

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.

Full Title of Study: “Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 15, 2021

Interventions

  • Procedure: Erector spinae plane block
    • Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.
  • Other: sham block
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: ESP block group
    • The bilateral erector spine plane (ESP) block will be performed with ultrasound guided, preoperatively. Following antiseptic preparation of block site with povidone iodine, ultrasound probe will be placed 3 cm lateral to spine at T5 level. After identifying the erector spinae muscle and transverse process, the overlying skin will be infiltrated with local anesthetics and 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL 1% lidocaine) will be injected deep to the erector spinae muscle. The same procedure will be performed on the other side. Also, patients will receive intravenous patient controlled analgesia with morphine, and 1 g acetaminophen for supplemental analgesia if pain score raises over 5/10 on NRS and 50 mg meperidine for rescue analgesic for persistent pain. Interventions: Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization
  • Sham Comparator: sham block
    • A sham block will be performed while looking for intended location for ESP block placement. Skin will be infiltrated with local anesthetics but ESP block will not be performed, instead of ESP block 2 mL subcutaneous saline injection will be applied. Intervention: Sham block Other: Standard Pain Followup and Monitorization

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative morphine consumption
    • Time Frame: 24 hours
    • Morphine consumption in Patient Controlled Analgesia device

Secondary Measures

  • Intraoperative anesthetic consumption
    • Time Frame: During operation time
    • Intraoperative total doses of remifentanil, pentothal, desflurane consumption
  • Extubation and recovery time
    • Time Frame: Through surgical operation completion
    • Using modified aldrete score
  • 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”).
  • 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.
  • 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.
  • Supplemental and rescue analgesic requirement
    • Time Frame: 24 hours
    • Total supplemental and rescue analgesic consumption
  • 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.
  • Bilateral shoulder mobility
    • Time Frame: Preoperative and postoperative 4th, 8th, 12th, and 24th hours
    • It will be assessed with ability of shoulder abduction degree
  • 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
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cukurova University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Demet Laflı Tunay, Principal Investigator – Cukurova University

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