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Completed

NCT Number: NCT06962085

Sacral Erector Spinae Plane Block 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Adıyaman University Faculty of Medicine Anesthesiology and Reanimation

Merkez, Adıyaman Province, 02100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Patients who did not agree to participate in the study,
  • Those under 18 years old
  • ASA III-IV risk group

Treatment and study plan

sacral erector spinae plane block group

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

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.

Primary outcomes

  1. postoperative opioid use

    Time frame: 24 hours

    Opioid use will be recorded at 0, 2, 4, 6, 12 and 24 hours after the operation.

Secondary outcomes

  1. intraoperative opioid use

    Time frame: intraoperative

    Total opioid use (remifentanil) during the operation will be recorded.

  2. numerical pain score

    Time frame: 24 hours

    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'.

  3. QoR-15T (Turkish) quality of recovery scale

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Adiyaman University

Other

Registry information

Official study title

Effect of Sacral Erector Spinae Plane Block on Postoperative Pain in Transurethral Prostate Resection Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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