- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03744520
Sensorial Block Assessment of Erector Spinae Block
October 3, 2019 updated by: Onur Selvi
Assessment of Dermatomal Sensorial Block of Erector Spinae Plane Block: Randomized, Prospective, Study
Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries.
Regional techniques are well-described methods for postoperative analgesia.
However, the sensorial dermatomal spread of regional block varies depending on the multiple variables as the level of the block, local analgesic concentration etc.
The aim of this study is to observe dermatomal evaluation of sensorial block.
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
-
-
Maltepe
-
Istanbul, Maltepe, Turkey, 34843
- Maltepe University Medical Faculty
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patients who received successful erector spinae plane block for postoperative analgesia
Exclusion Criteria:
- Patients under 18 years old
- Patients who are not able to communicate with
- Patients who are on medication which may change the perception of pain.
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: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESP block group
The patients who had paravertebral interfacial plane block for postoperative analgesia
|
Local anesthetic infiltration is applied between the erector spinae muscle fascia and transverse process.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spread of sensorial block
Time Frame: in postoperative sixth hours
|
The sensorial block will be evaluated with dermatomal examination
|
in postoperative sixth hours
|
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)
November 15, 2018
Primary Completion (Actual)
October 3, 2019
Study Completion (Actual)
October 3, 2019
Study Registration Dates
First Submitted
October 25, 2018
First Submitted That Met QC Criteria
November 14, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
October 4, 2019
Last Update Submitted That Met QC Criteria
October 3, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sensorial Block assessment
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.
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