TURP(Transurethral Resection of Prostate)NCT06962085
Sacral Erector Spinae Plane Block in Transurethral Prostate Resection Surgery
A study testing sacral erector spinae plane block group and Opioid Analgesics in people with TURP(Transurethral Resection of Prostate), run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of bilateral sacral erector spinae plane block on hemodynamic values, postoperative pain, analgesic use and patient satisfaction during operative period in Transurethral Prostate Resection surgeries under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- TURP(Transurethral Resection of Prostate)
- What is being tested?
- sacral erector spinae plane block group and Opioid Analgesics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2025to 8 Jan 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were scheduled for transurethral prostate resection,
- Who agreed to participate in the study,
- Who were over 18 years old
- ASA I-II risk group
Who cannot join
- Patients who did not agree to participate in the study,
- Those under 18 years old
- ASA III-IV risk group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adıyaman University Faculty of Medicine Anesthesiology and Reanimation
Merkez, Adıyaman Province, 02100
About this study
Official title: Effect of Sacral Erector Spinae Plane Block on Postoperative Pain in Transurethral Prostate Resection Surgery
The aim of this study is to investigate the effects of bilateral sacral erector spinae plane block on hemodynamic values, postoperative pain, analgesic use and patient satisfaction during operative period in Transurethral Prostate Resection surgeries under general anesthesia.
Read the detailed description
The study included patients who were planned to undergo transurethral prostate resection, were informed about the study, and agreed to participate in the study with their written consent, were over 18 years of age, and were in the ASA I-II risk group. Those who did not agree to participate in the study, patients under 18 years of age, and those in the ASA III-IV risk group were excluded from the study. Patients who agreed to participate in the study were divided into two groups using the sealed envelope method, and general anesthesia was applied to both groups. In the group where the block was to be applied, bilateral sacral erector spinae plane block was performed with local anesthetic (10 mL 0.25% bupivacaine + 5 mL 1% lidocaine) after the 3rd sacral intermedian crest was visualized with preoperative ultrasound. No additional intervention was performed on the patients in the control group other than the surgical procedure and general anesthesia. The hemodynamic values (noninvasive blood pressure, heart rate, peripheral oxygen saturation) of all patients during the operation, total opioid use (remifentanil) during the surgery, and NRS, nausea/vomiting and tramadol amounts at 0, 2, 4, 6, 12, and 24 hours postoperatively were recorded and the values were compared in both groups. Thus, it was aimed to evaluate the effects of sacral erector spinae plane block in transurethral prostate resection operations.
- Being tested
- sacral erector spinae plane block group, Opioid Analgesics
- Keywords
- Bilateral sacral erector spinae plane block, Opioid consumption, Numerical pain scores, Quality of Recovery-15 (QoR-15T), TUR-P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral erector spinae plane block groupProcedure or surgery
In the block group, bilateral sacral erector spinae plane block (10 mL 0.25% bupivacaine (Marcaine %0,5. AstraZeneca Ltd, İstanbul, Türkiye) + 5 mL 1% lidocaine (Lidon 100 mg/ 5mL. ONFARMA İlaç San. Ve Tic. A.Ş, Ankara, Türkiye) will be performed in the lateral position with the help of ultrasound before surgery.
Opioid AnalgesicsDrug
Sacral arrector spine block will not be performed in this group. After general anesthesia, hemodynamic values (noninvasive blood pressure, heart rate, peripheral oxygen saturation) and total remifentanil (Rentanil 2 mg. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use will be recorded during the operation. Additionally, numerical pain scores and total meperidine (Aldine 100mg/2mL. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use at 0, 2, 4, 6, 12 and 24 hours after the operation will be recorded. At the 24th hour, the Turkish version of the Quality of Recovery-15 (QoR-15T) Questionnaire will be filled out and recorded.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | After general anesthesia is applied, hemodynamic values (noninvasive blood pressure, heart rate, peripheral oxygen saturation) and total remifentanil (Rentanil 2 mg. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use will be recorded during the operation and numerical pain scores and total meperidine (Aldine 100mg/2mL. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use at 0, 2, 4, 6, 12 and 24 hours after the operation will be recorded. At the 24th hour, the Turkish version of the Quality of Recovery-15 (QoR-15T) Questionnaire will be filled out and recorded. Receives: Drug: Opioid Analgesics |
| sacral erector spinae plane block group | Active comparator | In the group where the block will be applied, bilateral sacral erector spinae plane block will be performed with local anesthetic (10 mL 0.25% bupivacaine (Marcaine %0,5. AstraZeneca Ltd, İstanbul, Türkiye)+ 5 mL 1% lidocaine (Lidon 100 mg/ 5mL. ONFARMA İlaç San. Ve Tic. A.Ş, Ankara, Türkiye) after the sacral intermedian crest is visualized with preoperative ultrasound. After general anesthesia is applied, hemodynamic values (noninvasive blood pressure, heart rate, peripheral oxygen saturation) and total remifentanil (Rentanil 2 mg. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use will be recorded during the operation. Additionally, numerical pain scores and total meperidine (Aldine 100mg/2mL. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use at 0, 2, 4, 6, 12 and 24 hours after the operation will be recorded. At the 24th hour, the Turkish version of the Quality of Recovery-15 (QoR-15T) Questionnaire will be filled out and recorded. Receives: Procedure: sacral erector spinae plane block group; Drug: Opioid Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid use
Opioid use will be recorded at 0, 2, 4, 6, 12 and 24 hours after the operation.
Measured: 24 hours
Secondary outcomes (3)
intraoperative opioid use
Total opioid use (remifentanil) during the operation will be recorded.
Measured: intraoperative
numerical pain score
Postoperatively, numerical pain scores (NRS) will be recorded at 0, 2, 4, 6, 12 and 24 hours and these values will be compared and recorded in both groups. Numerical pain scores (NRS) are the scale used to measure pain intensity. This scale gives a numerical value between 0 and 10, with 0 being 'no pain' and 10 being 'worst imaginable pain'.
Measured: 24 hours
QoR-15T (Turkish) quality of recovery scale
The Quality of Recovery-15 (QoR-15) at 24 hours scale is a patient-reported outcome questionnaire that measures the quality of postoperative recovery. The validity of Quality of Recovery-15 (QoR-15) has been proven in many languages. In our study, the Turkish Quality of Recovery-15 (QoR-15T) will be used to measure postoperative recovery in the Turkish population. The Turkish Quality of Recovery-15 (QoR-15T) scale consists of 2 parts and a total of 15 questions are asked to patients. Patients can score each question between 0 and 10, so the total Turkish Quality of Recovery-15 (QoR-15T) score can range from 0 to 150. A higher score indicates a better recovery quality.
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 posted8 May 2025
- Study start5 Sep 2025
- Primary completion1 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TURP(Transurethral Resection of Prostate)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups as Control and Block groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime Tosun, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962085
- Sponsor's protocol ID
- ADYU-AR-FT-01
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2025
- Last updated
- 3 Mar 2026
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sacral Erector Spinae Plane Block on Postoperative Pain in Transurethral Prostate Resection Surgery
- ClinicalTrials.gov ID
- NCT06962085
- Acronym / sponsor ID
- ADYU-AR-FT-01
- Keywords
- Bilateral sacral erector spinae plane block, Opioid consumption, Numerical pain scores, Quality of Recovery-15 (QoR-15T), TUR-P
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 8 May 2025 (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 aim of this study is to investigate the effects of bilateral sacral erector spinae plane block on hemodynamic values, postoperative pain, analgesic use and patient satisfaction during operative period in Transurethral Prostate Resection surgeries under general anesthesia.
Detailed description
The study included patients who were planned to undergo transurethral prostate resection, were informed about the study, and agreed to participate in the study with their written consent, were over 18 years of age, and were in the ASA I-II risk group. Those who did not agree to participate in the study, patients under 18 years of age, and those in the ASA III-IV risk group were excluded from the study. Patients who agreed to participate in the study were divided into two groups using the sealed envelope method, and general anesthesia was applied to both groups. In the group where the block was to be applied, bilateral sacral erector spinae plane block was performed with local anesthetic (10 mL 0.25% bupivacaine + 5 mL 1% lidocaine) after the 3rd sacral intermedian crest was visualized with preoperative ultrasound. No additional intervention was performed on the patients in the control group other than the surgical procedure and general anesthesia. The hemodynamic values (noninvasive blood pressure, heart rate, peripheral oxygen saturation) of all patients during the operation, total opioid use (remifentanil) during the surgery, and NRS, nausea/vomiting and tramadol amounts at 0, 2, 4, 6, 12, and 24 hours postoperatively were recorded and the values were compared in both groups. Thus, it was aimed to evaluate the effects of sacral erector spinae plane block in transurethral prostate resection operations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Two groups as Control and Block groups
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Opioid AnalgesicsAfter general anesthesia is applied, hemodynamic values (noninvasive blood pressure, heart rate, peripheral oxygen saturation) and total remifentanil (Rentanil 2 mg. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use will be recorded during the operation and numerical pain scores and total meperidine (Aldine 100mg/2mL. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use at 0, 2, 4, 6, 12 and 24 hours after the operation will be recorded. At the 24th hour, the Turkish version of the Quality of Recovery-15 (QoR-15T) Questionnaire will be filled out and recorded. |
| sacral erector spinae plane block group | Active comparator | Procedure: sacral erector spinae plane block group, Drug: Opioid AnalgesicsIn the group where the block will be applied, bilateral sacral erector spinae plane block will be performed with local anesthetic (10 mL 0.25% bupivacaine (Marcaine %0,5. AstraZeneca Ltd, İstanbul, Türkiye)+ 5 mL 1% lidocaine (Lidon 100 mg/ 5mL. ONFARMA İlaç San. Ve Tic. A.Ş, Ankara, Türkiye) after the sacral intermedian crest is visualized with preoperative ultrasound. After general anesthesia is applied, hemodynamic values (noninvasive blood pressure, heart rate, peripheral oxygen saturation) and total remifentanil (Rentanil 2 mg. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use will be recorded during the operation. Additionally, numerical pain scores and total meperidine (Aldine 100mg/2mL. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use at 0, 2, 4, 6, 12 and 24 hours after the operation will be recorded. At the 24th hour, the Turkish version of the Quality of Recovery-15 (QoR-15T) Questionnaire will be filled out and recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who were scheduled for transurethral prostate resection,
- Who agreed to participate in the study,
- Who were over 18 years old
- ASA I-II risk group
Key exclusion criteria (3 listed)
- Patients who did not agree to participate in the study,
- Those under 18 years old
- ASA III-IV risk group
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 |
|---|---|---|
| sacral erector spinae plane block groupIn the block group, bilateral sacral erector spinae plane block (10 mL 0.25% bupivacaine (Marcaine %0,5. AstraZeneca Ltd, İstanbul, Türkiye) + 5 mL 1% lidocaine (Lidon 100 mg/ 5mL. ONFARMA İlaç San. Ve Tic. A.Ş, Ankara, Türkiye) will be performed in the lateral position with the help of ultrasound before surgery. | Procedure or surgery | sacral erector spinae plane block group |
| Opioid AnalgesicsSacral arrector spine block will not be performed in this group. After general anesthesia, hemodynamic values (noninvasive blood pressure, heart rate, peripheral oxygen saturation) and total remifentanil (Rentanil 2 mg. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use will be recorded during the operation. Additionally, numerical pain scores and total meperidine (Aldine 100mg/2mL. VEM İlaç San. Ve Tic. A.Ş, İstanbul, Türkiye) use at 0, 2, 4, 6, 12 and 24 hours after the operation will be recorded. At the 24th hour, the Turkish version of the Quality of Recovery-15 (QoR-15T) Questionnaire will be filled out and recorded. | Drug | control group, sacral erector spinae plane block group |
Primary outcome
postoperative opioid use
Time frame: 24 hours
Opioid use will be recorded at 0, 2, 4, 6, 12 and 24 hours after the operation.
3 secondary outcomes
intraoperative opioid use
Time frame: intraoperative
numerical pain score
Time frame: 24 hours
QoR-15T (Turkish) quality of recovery scale
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 3 Mar 2026.
- 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.
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 sacral erector spinae plane block group and Opioid Analgesics in people with TURP(Transurethral Resection of Prostate), run by Adiyaman 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 4 inclusion and 3 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 3 Mar 2026. 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?
postoperative opioid use (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 3 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.