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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621345
• Other study ID #: CukurovaUniv
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Hypertrophy
• Hypertrophy
• Postoperative Pain

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