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

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:

  1. American Society of Anesthesiologist (ASA) physical status I-II,
  2. ages 18-75 years,
  3. undergoing laparoscopic cholecystectomy

Exclusion Criteria:

  1. Patients with cardiac, endocrinological, neurological diseases,
  2. patients with coagulation disorders
  3. allergy to local anesthetics
  4. 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.

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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