Breast Hypertrophy, Postoperative Pain
Conditions
Brief summary
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.
Interventions
PROCEDUREErector 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.
OTHERsham 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.
Sponsors
Cukurova University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morphine consumption | 24 hours | Morphine consumption in Patient Controlled Analgesia device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extubation and recovery time | Through surgical operation completion | Using modified aldrete score |
| Pain assessed by NRS | 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 | 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 | 24 hours | Opioid related side effects such as nause/vomiting, pruritis, bradycardia, hypotension will be evaluated at intervals up to 24 hours. |
| Intraoperative anesthetic consumption | During operation time | Intraoperative total doses of remifentanil, pentothal, desflurane consumption |
| Patient satisfaction assessment | 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 | Preoperative and postoperative 4th, 8th, 12th, and 24th hours | It will be assessed with ability of shoulder abduction degree |
| Length of stay in hospital | Until discharge from hospital, up to 7 days postoperatively | Duration of length of stay in hospital will be recorded |
| Rate of block related complications | Until discharge from hospital, up to 7 days postoperatively | Rate of block related complications such as hematoma, nerve deficit, pneumothorax etc. will be recoded. |
| Supplemental and rescue analgesic requirement | 24 hours | Total supplemental and rescue analgesic consumption |
Countries
Turkey (Türkiye)
Outcome results
None listed