- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130945
Cost Effect of Erector Spina Plane Block
June 30, 2020 updated by: Kevser Peker, Kırıkkale University
Effect of Erector Spina Plane Block on Cost of Laparoscopic Cholesistectomy Anesthesia
Use of erector spina plane (ESP) block for postoperative analgesia is continuously increasing.
However, few studies have investigated intraoperative effects of ESP block.
The investigators aim to study the effects of ESP block in terms of cost-effectiveness, consumption of inhalation agents and opioids in perioperative and postoperative period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Erector spina plane (ESP) block has analgesic efficiency and its popularity is growing steadily.
ESP block forms a sensorial block by local anesthetic infiltration between the musculus erector spina and facia.
ESP block given to participants undergoing laparoscopic cholecystectomy for postoperative opioid analgesia resulted in a decrease of postoperative pain scores in the first 24 h.
Due to increases in health expenditure, cost control is becoming more and more important.
Cost-effective studies are important in healthcare economics.
Inhaled anesthetics used in anesthesia departments account for about 20% of total anesthetic agents.
Local anesthetic agents decrease the minimum alveolar concentration (MAC) value of inhaled agents.
And also in perioperative and post operative period, the anesthetic management often need to be supported with opioid drugs.
The investigators think that ESP block has analgesic effects and decreases the consumption of inhalation agents.
The investigators aim to investigate the cost-effectiveness of ESP block in anesthetic applications in laparoscopic procedures.
Study Type
Interventional
Enrollment (Actual)
81
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
-
-
-
Kırıkkale, Turkey, 71450
- Kırıkkale Univercity Faculty of Medicine 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
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologist (ASA) physical status I-II,
- ages 18-75 years,
- undergoing laparoscopic cholecystectomy
Exclusion Criteria:
- Patients with cardiac, endocrinological, neurological diseases,
- patients with coagulation disorders
- allergy to local anesthetics
- Operations that started as laparoscopy but transitioned to open surgery for a surgical reason
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group 1
patients with erector spine plane block
|
in preopererative period, ESP block is going to utilise for postoperative analgesia for patients who undergo laparoscopic procedure and cost analysis will make after the end of 24 hour of operation
|
No Intervention: group 2
patients without erector spine plane block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the formula of consumption of inhaled agent
Time Frame: 30 minute after the operation
|
the formula which includes fresh gas flow, valume of inhaled agent vapor, sevoflurane concentration
|
30 minute after the operation
|
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)
September 11, 2019
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
October 16, 2019
First Submitted That Met QC Criteria
October 16, 2019
First Posted (Actual)
October 18, 2019
Study Record Updates
Last Update Posted (Actual)
July 1, 2020
Last Update Submitted That Met QC Criteria
June 30, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- cost effectiveness
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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