NephrectomyNCT04703634
The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.
A study testing erector spinae block (ESP) in people with Nephrectomy, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephrectomy
- What is being tested?
- erector spinae block (ESP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2021to 17 May 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To undergo partial or total nephrectomy surgery
- To be in ASA I-II classification
- To be between the ages of 18-65.
- Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly.
- Being in good mental and psychological health
- To accept to participate in the study.
Who cannot join
- Being in ASA III or IV class with a high risk of anesthesia
- Being outside the age range of 18-65
- Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application.
- Not being mentally and psychologically healthy
- Those who are allergic to the active substance, patients using antiepileptic drugs
- Those with severe hepatic and renal failure
Show all 9Show fewer
- Those who have long-term use of nonsteroidal anti-inflammatory and opioid analgesic,
- Those with diabetes and other neuropathic diseases
- Patients who cannot use patient-controlled analgesia (PCA) device
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Namık Kemal University
Tekirdağ, Süleymanpaşa, 59100
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephrectomy
- Being tested
- erector spinae block (ESP)
- Keywords
- erector spinae block, nephrectomy, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae block (ESP)Procedure or surgery
Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra
| Study group | Role | What they receive |
|---|---|---|
| erector spinae group | Experimental | 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. Receives: Procedure: erector spinae block (ESP) |
| placebo group | Placebo comparator | No block transaction will be applied to this group. Only postoperative analgesia methods will be used for this group as specified in the protocol. Receives: Procedure: erector spinae block (ESP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
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").
Measured: 24 hours
Secondary outcomes (2)
Recovery analgesia
Secondary outcome measures will be routine (paracetamol or tramadol PCA) or recovery. Analgesic use will be recorded within the first 24 hours.
Measured: 24 hours
postoperative nausea and vomiting
The severity of nausea and vomiting 4-point scale (none, mild, moderate, and severe). As will be recorded by the nurses in the ward.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start14 Jan 2021
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- It is a single centre, randomized, prospective method comparison study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayhan ŞAHİN, Namik Kemal University
- Investigators
- Ayhan ŞAHİN, Study chair, Namık Kemal University Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703634
- Sponsor's protocol ID
- Interventional
- Status last verified
- Aug 2021
- First submitted
- 6 Jan 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-guided Erector Spinae Block on Postoperative Analgesic Consumption in Patients Undergoing Nephrectomy. Prospective Randomized Single-center Study.
- ClinicalTrials.gov ID
- NCT04703634
- Acronym / sponsor ID
- Interventional
- Conditions
- Nephrectomy
- Keywords
- erector spinae block, nephrectomy, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 11 Jan 2021 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- It is a single centre, randomized, prospective method comparison study.
| Arm | Type | Receives |
|---|---|---|
| erector spinae group | Experimental | Procedure: erector spinae block (ESP)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. |
| placebo group | Placebo comparator | Procedure: erector spinae block (ESP)No block transaction will be applied to this group. Only postoperative analgesia methods will be used for this group as specified in the protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To undergo partial or total nephrectomy surgery
- To be in ASA I-II classification
- To be between the ages of 18-65.
- Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly.
- Being in good mental and psychological health
Key exclusion criteria (9 listed)
- Being in ASA III or IV class with a high risk of anesthesia
- Being outside the age range of 18-65
- Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application.
- Not being mentally and psychologically healthy
- Those who are allergic to the active substance, patients using antiepileptic drugs
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 spinae block (ESP)Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra | Procedure or surgery | erector spinae group, placebo group |
Primary outcome
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").
2 secondary outcomes
Recovery analgesia
Time frame: 24 hours
postoperative nausea and vomiting
Time frame: 24 hours
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 Sep 2021.
- Individual participant dataSharing planned: Yes. 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.
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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.
Ayhan ŞAHİN study chair
Namık Kemal University Medicine Faculty
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 spinae block (ESP) in people with Nephrectomy, run by Namik Kemal 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 6 inclusion and 9 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 Sep 2021. 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. Some participants in this study may receive a placebo. 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?
Numerical Rating Scale (NRS) (time frame: 24 hours). 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 Sep 2021.