Sacral Erector Spinae Plane Block in Transurethral Prostate Resection Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2026-01-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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TURP(Transurethral Resection of Prostate)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups as Control and Block groups

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Nurses who evaluate the pain score and satisfaction survey during the postoperative follow-up of the patients will be blinded.

Study Groups

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control group

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.

Group Type ACTIVE_COMPARATOR

Opioid Analgesics

Intervention Type DRUG

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.

sacral erector spinae plane block group

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.

Group Type ACTIVE_COMPARATOR

sacral erector spinae plane block group

Intervention Type PROCEDURE

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 Analgesics

Intervention Type DRUG

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.

Interventions

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sacral erector spinae plane block group

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.

Intervention Type PROCEDURE

Opioid Analgesics

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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