Cost EffectivenessNCT04130945
Cost Effect of Erector Spina Plane Block
A study testing erector spina plane block, cost analysis in people with Cost Effectiveness, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cost Effectiveness
- What is being tested?
- erector spina plane block, cost analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist (ASA) physical status I-II,
- ages 18-75 years,
- undergoing laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale Univercity Faculty of Medicine Hospital
Kirikkale, 71450
About this study
Official title: 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.
Read the 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.
- Conditions
- Cost Effectiveness
- Being tested
- erector spina plane block, cost analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spina plane block, cost analysisOther
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
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | patients with erector spine plane block Receives: Other: erector spina plane block, cost analysis |
| group 2 | No intervention | patients without erector spine plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the formula of consumption of inhaled agent
the formula which includes fresh gas flow, valume of inhaled agent vapor, sevoflurane concentration
Measured: 30 minute after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start11 Sep 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cost EffectivenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Peker, Kırıkkale University
- Investigators
- Kevser Peker, Principal investigator, Kırıkkale University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130945
- Sponsor's protocol ID
- cost effectiveness
- Status last verified
- Jun 2020
- First submitted
- 16 Oct 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Erector Spina Plane Block on Cost of Laparoscopic Cholesistectomy Anesthesia
- ClinicalTrials.gov ID
- NCT04130945
- Acronym / sponsor ID
- cost effectiveness
- Conditions
- Cost Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Other: erector spina plane block, cost analysispatients with erector spine plane block |
| group 2 | No intervention | –patients without erector spine plane block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist (ASA) physical status I-II,
- ages 18-75 years,
- undergoing laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erector spina plane block, cost analysisin 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 | Other | group 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevser Peker principal investigator
Kırıkkale University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spina plane block, cost analysis in people with Cost Effectiveness, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the formula of consumption of inhaled agent (time frame: 30 minute after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.