Erector Spinae Plane BlockNCT05170373
ESP Block in Radical Prostatectomy
A study testing ESP block in people with Erector Spinae Plane Block, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Our study aimed to examine the effects of ultrasound guided erector spinae plane block in radical prostatectomy surgery on pain and surgical stress response, to reduce adrenocortical and sympathetic discharge due to anesthesia and surgery, and to reduce peroperative opioid analgesic consumption. Read more about this study
- Who is it for?
- Ages 30 to 74 years, men only
- Conditions the study is for
- Erector Spinae Plane Block
- What is being tested?
- ESP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Jun 2020
- 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 30 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
Who cannot join
- diabetes
- coagulopathy
- local anesthetic
- drug allergy
- long hospitalization history,
- hormone disorder
Show all 10Show fewer
- advanced organ failure
- history of steroid use
- vertebral anomalies
- mental retardation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: Effects of Ultrasound Guided Erector Spinae Plane Block in Radical Prostatectomy Surgery on Pain and Surgical Stress Response
Our study aimed to examine the effects of ultrasound guided erector spinae plane block in radical prostatectomy surgery on pain and surgical stress response, to reduce adrenocortical and sympathetic discharge due to anesthesia and surgery, and to reduce peroperative opioid analgesic consumption.
Read the detailed description
In this study 46 patients between the ages of 30-74, American Society of Anesthesiologists (ASA) score I-II and undergoing radical prostatectomy surgery at T.R. Ministry Of Health İstanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital were included. The patients were randomly divided into two groups as ESPB applied Group B (n=23) and not Group K (n=23). Patient-controlled analgesia (PCA) was initiated in all patients for postoperative analgesia. Patients' demographic data (age, gender, ASA score), intraoperative hemodynamic data, intraoperative and postoperative additional narcotic consumption, postoperative Numeric Rating Scale (NRS) scores (postoperative 0, 5 and 20 minutes and Then, 1, 3, 6, 12, 18 and 24 h), postoperative nausea-vomiting scores and possible complications related to block and / or surgery were recorded.Intraoperative MAP, HR, SpO2, BIS values of patients in both groups were recorded every 5 minutes. Blood glucose, insulin, cortisol, prolactin and C-reactive protein (CRP) were studied three times; preop morning at 6:00, intraoperative when surgical incision closing and postoperative 24h. in order to evaluate the surgical stress response in the patients.
- Conditions
- Erector Spinae Plane Block
- Being tested
- ESP block
- Keywords
- Erektor Spinae Plane Block, Postoperative Analgesia, Surgical Stress Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockProcedure or surgery
Before general anesthesia, ESP block was applied from the T12 vertebra level with 10 ml 0.5% bupivacaine HCL 5 ml 2% lidocaine HCL 5 ml 0.9% isotonic NaCl mixture
| Study group | Role | What they receive |
|---|---|---|
| ESP group | Active comparator | Not described Receives: Procedure: ESP block |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale
Between 1-10. 1: no pain, 10: worst possible pain
Measured: postoperative 24 hours.
Blood glucose
mg /dL
Measured: postoperative 24 hours.
insulin
µIU/mL
Measured: postoperative 24 hours.
cortisol
µg/dL
Measured: postoperative 24 hours.
prolactin
µg/L
Measured: postoperative 24 hours.
C-reactive protein
mg/L
Measured: postoperative 24 hours.
Secondary outcomes (1)
Remifentanil Consumption Speed
µg /kg/dk
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Feb 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Turan, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170373
- Sponsor's protocol ID
- IstanbulMU ESPB
- Status last verified
- Dec 2021
- First submitted
- 3 Nov 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound Guided Erector Spinae Plane Block in Radical Prostatectomy Surgery on Pain and Surgical Stress Response
- ClinicalTrials.gov ID
- NCT05170373
- Acronym / sponsor ID
- IstanbulMU ESPB
- Conditions
- Erector Spinae Plane Block
- Keywords
- Erektor Spinae Plane Block, Postoperative Analgesia, Surgical Stress Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 28 Dec 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.
Our study aimed to examine the effects of ultrasound guided erector spinae plane block in radical prostatectomy surgery on pain and surgical stress response, to reduce adrenocortical and sympathetic discharge due to anesthesia and surgery, and to reduce peroperative opioid analgesic consumption.
Detailed description
In this study 46 patients between the ages of 30-74, American Society of Anesthesiologists (ASA) score I-II and undergoing radical prostatectomy surgery at T.R. Ministry Of Health İstanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital were included. The patients were randomly divided into two groups as ESPB applied Group B (n=23) and not Group K (n=23). Patient-controlled analgesia (PCA) was initiated in all patients for postoperative analgesia. Patients' demographic data (age, gender, ASA score), intraoperative hemodynamic data, intraoperative and postoperative additional narcotic consumption, postoperative Numeric Rating Scale (NRS) scores (postoperative 0, 5 and 20 minutes and Then, 1, 3, 6, 12, 18 and 24 h), postoperative nausea-vomiting scores and possible complications related to block and / or surgery were recorded.Intraoperative MAP, HR, SpO2, BIS values of patients in both groups were recorded every 5 minutes. Blood glucose, insulin, cortisol, prolactin and C-reactive protein (CRP) were studied three times; preop morning at 6:00, intraoperative when surgical incision closing and postoperative 24h. in order to evaluate the surgical stress response in the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP group | Active comparator | Procedure: ESP block |
| control group | No intervention | – |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II
Key exclusion criteria (10 listed)
- diabetes
- coagulopathy
- local anesthetic
- drug allergy
- long hospitalization history,
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 |
|---|---|---|
| ESP blockBefore general anesthesia, ESP block was applied from the T12 vertebra level with 10 ml 0.5% bupivacaine HCL 5 ml 2% lidocaine HCL 5 ml 0.9% isotonic NaCl mixture | Procedure or surgery | ESP group |
Primary outcome
Numeric Pain Scale
Time frame: postoperative 24 hours.
Between 1-10. 1: no pain, 10: worst possible pain
Blood glucose
Time frame: postoperative 24 hours.
mg /dL
insulin
Time frame: postoperative 24 hours.
µIU/mL
cortisol
Time frame: postoperative 24 hours.
µg/dL
prolactin
Time frame: postoperative 24 hours.
µg/L
C-reactive protein
Time frame: postoperative 24 hours.
mg/L
1 secondary outcome
Remifentanil Consumption Speed
Time frame: 3 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 28 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP block in people with Erector Spinae Plane Block, run by Istanbul Medeniyet 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 1 inclusion and 10 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 28 Dec 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. 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?
Numeric Pain Scale (time frame: postoperative 24 hours.). The study lists 6 primary outcomes in all. 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 28 Dec 2021.