Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia

Pain, Postoperative Clinical Trial

Official title:

Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia in Reduction Mammoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558880
• Other study ID #: 2017/11-20
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: June 2018
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 30, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Hypertrophy
• Hypertrophy
• Pain, Postoperative

Intervention

Procedure:
• Erector Spinae Plane Block
Erector Spinae Plane Block was performed
• Tumescent Anesthesia
Tumescent Anesthesia was applied

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University Hospital	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of analgesic consumptions	Total tramadol consumptions with patient controlled device	24 hour
Secondary	Numeric Pain Rating Scale	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").	30 minute, 1,2,4,6,12,24 hour