The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.

August 31, 2021 updated by: Ayhan ŞAHİN, Namik Kemal University

The Effect of Ultrasound-guided Erector Spinae Block on Postoperative Analgesic Consumption in Patients Undergoing Nephrectomy. Prospective Randomized Single-center Study.

The main purpose of this study is to evaluate the postoperative effect of erector spinae block in patients undergoing nephrectomy that causes both visceral and somatic pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed and potential risks about the study, all patients have given written consent will undergo 24 hours screening for the analgesic effect of erector spinae block after nephrectomy. Patients meeting the criteria were randomly selected in double-blind manner 1:1 ratio to erector spiane block or not.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Süleymanpaşa
      • Tekirdağ, Süleymanpaşa, Turkey, 59100
        • Namık Kemal University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. To undergo partial or total nephrectomy surgery
  2. To be in ASA I-II classification
  3. To be between the ages of 18-65.
  4. Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly.
  5. Being in good mental and psychological health
  6. To accept to participate in the study.

Exclusion Criteria:

  1. Being in ASA III or IV class with a high risk of anesthesia
  2. Being outside the age range of 18-65
  3. Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application.
  4. Not being mentally and psychologically healthy
  5. Those who are allergic to the active substance, patients using antiepileptic drugs
  6. Those with severe hepatic and renal failure
  7. Those who have long-term use of nonsteroidal anti-inflammatory and opioid analgesic,
  8. Those with diabetes and other neuropathic diseases
  9. Patients who cannot use patient-controlled analgesia (PCA) device

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: erector spinae group
All blocks will be done under general anesthesia. Using a 6-10 MHz linear ultrasound (Esaote my-lab 6, Italy). With the ultrasonography device of our clinic, the side of the nephrectomy surgery will be performed with the position of the nephrectomy, and the position (lateral decubitus) is given to the patient. The thoracic 10th vertebra will be found under ultrasound guidance. After the T12 transverse protrusion is seen by sliding 3 cm laterally from the midline, 30 ml of 0.25% Bupivacaine will be injected under the erector spinae muscle above it.
Procedure: erector spinae block (ESP)
Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra
PLACEBO_COMPARATOR: placebo group
No block transaction will be applied to this group. Only postoperative analgesia methods will be used for this group as specified in the protocol.
Procedure: erector spinae block (ESP)
Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS)
Time Frame: 24 hours
Numerical Rating Scale (NRS) will be used for postoperative evaluation. NRS is a segmented digital version of the visual analog scale. Selecting an integer (0-10 integers) by a responder in (VAS). It is accepted as one dimensional-the measure of pain intensity in adults. The 11-point numerical scale ranges from "0" to "10," representing a pain ("no pain"). 10 ("as bad pain as you can imagine"), or ("the worst pain imaginable").
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recovery analgesia
Time Frame: 24 hours
Secondary outcome measures will be routine (paracetamol or tramadol PCA) or recovery. Analgesic use will be recorded within the first 24 hours.
24 hours
postoperative nausea and vomiting
Time Frame: 24 hours
The severity of nausea and vomiting 4-point scale (none, mild, moderate, and severe). As will be recorded by the nurses in the ward.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Namik Kemal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ayhan ŞAHİN, Namık Kemal University Medicine Faculty

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant data will be shared as much as the tasks described in the study. A meeting will be held at the end of the research, and the statistical data results will be shared. Dr. Ayhan Şahin is responsible.

IPD Sharing Time Frame

starting after 6 months publication

IPD Sharing Access Criteria

After publication, sharing will be made according to the journal criteria.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings