The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
Primary Purpose
Postoperative Pain, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Intravenous Morphine patient controlled analgesia device
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring erector spinae plane block, breast surgery, postoperative pain
Eligibility Criteria
Inclusion Criteria:
- 25-70 years of age
- ASA I-II
- Undergoing elective breast cancer surgery
Exclusion Criteria:
- obesity (body mass index >35 kg/m2)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs.
Sites / Locations
- Kocaeli University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Block Group
Control Group
Arm Description
Erector Spinae Plane Block administered group
Control group
Outcomes
Primary Outcome Measures
Morphine consumption
Secondary Outcome Measures
Full Information
NCT ID
NCT03415646
First Posted
January 10, 2018
Last Updated
March 7, 2018
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT03415646
Brief Title
The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
Official Title
The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 3, 2018 (Actual)
Primary Completion Date
March 5, 2018 (Actual)
Study Completion Date
March 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran 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
Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Breast Cancer
Keywords
erector spinae plane block, breast surgery, postoperative pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Block Group
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block administered group
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
erector spinae plane block with double level injection will be administered before the surgery
Intervention Type
Device
Intervention Name(s)
Intravenous Morphine patient controlled analgesia device
Intervention Description
24 hour morphine consumption will be recorded
Primary Outcome Measure Information:
Title
Morphine consumption
Time Frame
24 hour postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
25-70 years of age
ASA I-II
Undergoing elective breast cancer surgery
Exclusion Criteria:
obesity (body mass index >35 kg/m2)
infection of the skin at the site of needle puncture area
patients with known allergies to any of the study drugs
coagulopathy
recent use of analgesic drugs.
Facility Information:
Facility Name
Kocaeli University Hospital
City
İzmit
State/Province
Kocaeli
ZIP/Postal Code
41340
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
We'll reach out to this number within 24 hrs