Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia

NCT03558880 | Completed

• 1 other identifier: 2017/11-20
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Hypertrophy; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Use of analgesic consumptions

  Total tramadol consumptions with patient controlled device

  24 hour

Secondary Outcomes (1)

• Numeric Pain Rating Scale

  30 minute, 1,2,4,6,12,24 hour

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Before the general anesthesia Erector Spinae Plane Block was performed.

Procedure: Erector Spinae Plane Block

Tumescent Anesthesia

ACTIVE COMPARATOR

After the general anesthesia was given, 1 mL of 0.1% adrenaline (1/1000) and as 20 mL of 0.5% bupivacaine solution of tumescent in a total of 1000 mL Ringer's lactate applied by the surgeon applied equally to both breasts

Procedure: Tumescent Anesthesia

Interventions

Erector Spinae Plane Block PROCEDURE

Erector Spinae Plane Block was performed

Erector Spinae Plane Block

Tumescent Anesthesia PROCEDURE

Tumescent Anesthesia was applied

Tumescent Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University Hospital

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (1)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

MeSH Terms

Conditions

Gigantomastia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Gözen Öksüz, M.D.

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 30, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)