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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03621345
Other study ID # CukurovaUniv
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2018
Est. completion date September 1, 2021

Study information

Verified date February 2023
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Cukurova University Adana Sariçam

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

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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