The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
March 7, 2018 updated by: Can AKSU, Kocaeli University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kocaeli
-
İzmit, Kocaeli, Turkey, 41340
- Kocaeli University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Block Group
Erector Spinae Plane Block administered group
|
24 hour morphine consumption will be recorded
erector spinae plane block with double level injection will be administered before the surgery
|
|
Sham Comparator: Control Group
Control group
|
24 hour morphine consumption will be recorded
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Morphine consumption
Time Frame: 24 hour postoperatively
|
24 hour postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2018
Primary Completion (Actual)
March 5, 2018
Study Completion (Actual)
March 7, 2018
Study Registration Dates
First Submitted
January 10, 2018
First Submitted That Met QC Criteria
January 23, 2018
First Posted (Actual)
January 30, 2018
Study Record Updates
Last Update Posted (Actual)
March 9, 2018
Last Update Submitted That Met QC Criteria
March 7, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-377
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.