Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia
Primary Purpose
Breast Hypertrophy, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Tumescent Anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Breast Hypertrophy
Eligibility Criteria
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
Sites / Locations
- Kahramanmaras Sutcu Imam University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Erector Spinae Plane Block
Tumescent Anesthesia
Arm Description
Before the general anesthesia Erector Spinae Plane Block was performed.
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
Outcomes
Primary Outcome Measures
Use of analgesic consumptions
Total tramadol consumptions with patient controlled device
Secondary Outcome Measures
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").
Full Information
NCT ID
NCT03558880
First Posted
June 5, 2018
Last Updated
July 31, 2018
Sponsor
Kahramanmaras Sutcu Imam University
1. Study Identification
Unique Protocol Identification Number
NCT03558880
Brief Title
Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia
Official Title
Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia in Reduction Mammoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Hypertrophy, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
Before the general anesthesia Erector Spinae Plane Block was performed.
Arm Title
Tumescent Anesthesia
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
Erector Spinae Plane Block was performed
Intervention Type
Procedure
Intervention Name(s)
Tumescent Anesthesia
Intervention Description
Tumescent Anesthesia was applied
Primary Outcome Measure Information:
Title
Use of analgesic consumptions
Description
Total tramadol consumptions with patient controlled device
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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").
Time Frame
30 minute, 1,2,4,6,12,24 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gözen Öksüz, M.D.
Organizational Affiliation
Kahramanmaras Sutcu Imam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University Hospital
City
Kahramanmaras
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27501016
Citation
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.
Results Reference
background
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Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia
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