Postoperative Pain Clinical Trial
Official title:
Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
Verified date | February 2023 |
Source | Cukurova University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 1, 2021 |
Est. primary completion date | August 15, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Cukurova University | Adana | Sariçam |
Lead Sponsor | Collaborator |
---|---|
Cukurova University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative morphine consumption | Morphine consumption in Patient Controlled Analgesia device | 24 hours | |
Secondary | Intraoperative anesthetic consumption | Intraoperative total doses of remifentanil, pentothal, desflurane consumption | During operation time | |
Secondary | Extubation and recovery time | Using modified aldrete score | Through surgical operation completion | |
Secondary | 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"). | 24 hours | |
Secondary | 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. | 24 hours | |
Secondary | 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. | 24 hours | |
Secondary | Supplemental and rescue analgesic requirement | Total supplemental and rescue analgesic consumption | 24 hours | |
Secondary | 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. | At the postoperative 24th hour | |
Secondary | Bilateral shoulder mobility | It will be assessed with ability of shoulder abduction degree | Preoperative and postoperative 4th, 8th, 12th, and 24th hours | |
Secondary | Length of stay in hospital | Duration of length of stay in hospital will be recorded | Until discharge from hospital, up to 7 days postoperatively | |
Secondary | Rate of block related complications | Rate of block related complications such as hematoma, nerve deficit, pneumothorax etc. will be recoded. | Until discharge from hospital, up to 7 days postoperatively |
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