Sacral Erector Spinae Plane Block in Transurethral Prostate Resection Surgery

NCT06962085 | Completed

• 1 other identifier: ADYU-AR-FT-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TURP(Transurethral Resection of Prostate)

Keywords

Bilateral sacral erector spinae plane block; Opioid consumption; Numerical pain scores; Quality of Recovery-15 (QoR-15T); TUR-P

Outcome Measures

Primary Outcomes (1)

• postoperative opioid use

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

  24 hours

Secondary Outcomes (3)

• intraoperative opioid use

  intraoperative

• numerical pain score

  24 hours

• QoR-15T (Turkish) quality of recovery scale

  24 hours

Study Arms (2)

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.

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.

Procedure: sacral erector spinae plane block group; Drug: Opioid Analgesics

Interventions

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.

sacral erector spinae plane block group

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.

control group; sacral erector spinae plane block group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since the patient group undergoing transurethral prostate surgery was male, only male gender was included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Adıyaman University Faculty of Medicine Anesthesiology and Reanimation

Merkez, Adıyaman Province, 02100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Nurses who evaluate the pain score and satisfaction survey during the postoperative follow-up of the patients will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two groups as Control and Block groups

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 8, 2025
• Study Start: September 5, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 8, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)