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

Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial

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 Overview

• Status: Completed
• Conditions: Postoperative Pain; Breast Hypertrophy
• Intervention / Treatment: Procedure: Erector spinae plane block; Other: sham block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sariçam
    • Adana, Sariçam, Turkey, 01100
      • Çukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ESP block group; The bilateral erector spine plane (ESP) block will be performed with ultrasound guided, preoperatively. Following antiseptic preparation of block site with povidone iodine, ultrasound probe will be placed 3 cm lateral to spine at T5 level. After identifying the erector spinae muscle and transverse process, the overlying skin will be infiltrated with local anesthetics and 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL 1% lidocaine) will be injected deep to the erector spinae muscle. The same procedure will be performed on the other side. Also, patients will receive intravenous patient controlled analgesia with morphine, and 1 g acetaminophen for supplemental analgesia if pain score raises over 5/10 on NRS and 50 mg meperidine for rescue analgesic for persistent pain. Interventions: Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization	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.
SHAM_COMPARATOR: sham block; A sham block will be performed while looking for intended location for ESP block placement. Skin will be infiltrated with local anesthetics but ESP block will not be performed, instead of ESP block 2 mL subcutaneous saline injection will be applied. Intervention: Sham block Other: Standard Pain Followup and Monitorization	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine consumption	Morphine consumption in Patient Controlled Analgesia device	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation and recovery time	Using modified aldrete score	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").	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.	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.	24 hours
Supplemental and rescue analgesic requirement	Total supplemental and rescue analgesic consumption	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.	At the postoperative 24th hour
Bilateral shoulder mobility	It will be assessed with ability of shoulder abduction degree	Preoperative and postoperative 4th, 8th, 12th, and 24th hours
Length of stay in hospital	Duration of length of stay in hospital will be recorded	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.	Until discharge from hospital, up to 7 days postoperatively
Intraoperative anesthetic consumption	Intraoperative total doses of remifentanil, pentothal, desflurane consumption	During operation time

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2018
• Primary Completion (ACTUAL): August 15, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: CukurovaUniv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No