Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia

Not Applicable

Completed

• Conditions: Breast Hypertrophy; Pain, Postoperative

• Registration Number: NCT03558880
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

In breast reduction surgery, pain control is usually performed with tumescent anesthesia, thoracic epidural anesthesia, intercostal nerve blocks and paravertebral block applications. Tumescent anesthesia is also preferred by plastic surgeons because of the varying risk of thoracic epidural anesthesia and paravertebral block applications.

After the Erector spinae block was first described by Forero in 2016, it was reported to have been applied in many cases, including breast surgery.

It is considered to be a safer block because of the presence of paravertebral block-like activity and the location where the needle is guided away from the pleura. The investigators aimed to compare postoperative analgesia consumption, pain scores and patient satisfaction of erector spine block with tumescent anesthesia in patients who underwent reduction mammoplasty operation under general anesthesia in this double-blind prospective randomized study.

Detailed Description

Patients aged 18-65 years undergoing bilateral reduction mammoplasty. Patients were randomly divided into two groups with closed envelope to perform tumescent anesthesia and erector spinae block.

All patients were premedicated with oral midazolam 0.5 mg/ kg preoperatively. All patients received standard general anesthesia protocol as induction with 2-3 mg/kg iv propofol and 1-1.5 mcg/kg fentanyl and 0.6 mg/kg iv rocuronium. Endotracheal intubations were performed 7.0 or 7.5 endotracheal tubes with the patient in a supine position. Anesthesia maintenance was with sevoflurane 0.5/kg/mg remifentanil infusion and in a 50% O2 -50% air mixture. Standard monitoring of the patients included of heart rate, invasive systolic, diastolic and mean blood pressure and peripheral oxygen saturation and the operating times were recorded.

At approximately 30 minutes before the end of surgery, 8mg dexketoprofen IV was administered to all patients. At the end of the operation, all the patients were performed with iv PCA(Patient Controlled Analgesia).

Demographic data such as age, weight, and height of the patients were recorded. After patients informed about pain score NRS (Numeric Pain Rating Scale) and patient satisfaction score ( one to ten) recorded by the nurse of PACU and ward.

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2018-06
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-15
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-30
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

The American Society of Anesthesiologists physical status classification I-III undergoing reduction mammoplasty

Exclusion Criteria

History of allergic reactions to local anesthetics Rash or infection at the injection site Anatomical abnormality Bleeding diatheses Coagulopathy liver diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Use of analgesic consumptions	24 hour	Total tramadol consumptions with patient controlled device

Secondary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	30 minute, 1,2,4,6,12,24 hour	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").

Trial Locations

Locations (1)

Kahramanmaras Sutcu Imam University Hospital; 🇹🇷 Kahramanmaras, Turkey