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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.
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.
Cukurova University
Adana, Sariçam, Turkey (Türkiye)
Postoperative morphine consumption
Morphine consumption in Patient Controlled Analgesia device
Time frame: 24 hours
Intraoperative anesthetic consumption
Intraoperative total doses of remifentanil, pentothal, desflurane consumption
Time frame: During operation time
Extubation and recovery time
Using modified aldrete score
Time frame: Through surgical operation completion
Pain assessed by NRS
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").
Time frame: 24 hours
Degree of sedation
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.
Time frame: 24 hours
Rate of opioid related side effects
Opioid related side effects such as nause/vomiting, pruritis, bradycardia, hypotension will be evaluated at intervals up to 24 hours.
Time frame: 24 hours
Supplemental and rescue analgesic requirement
Total supplemental and rescue analgesic consumption
Time frame: 24 hours
Patient satisfaction assessment
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.
Time frame: At the postoperative 24th hour
Bilateral shoulder mobility
It will be assessed with ability of shoulder abduction degree
Time frame: Preoperative and postoperative 4th, 8th, 12th, and 24th hours
Length of stay in hospital
Duration of length of stay in hospital will be recorded
Time frame: Until discharge from hospital, up to 7 days postoperatively
Rate of block related complications
Rate of block related complications such as hematoma, nerve deficit, pneumothorax etc. will be recoded.
Time frame: Until discharge from hospital, up to 7 days postoperatively
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