ESP Block in Radical Prostatectomy

NCT ID: NCT05170373

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-06-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESP group

Group Type: ACTIVE_COMPARATOR

ESP block

Intervention Type: PROCEDURE

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

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ESP block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA I-II

Exclusion Criteria

• diabetes
• coagulopathy
• local anesthetic
• drug allergy
• long hospitalization history,
• hormone disorder
• advanced organ failure
• history of steroid use
• vertebral anomalies
• mental retardation

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Damla Turan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Suleyman Yalcin City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IstanbulMU ESPB

Identifier Type: -

Identifier Source: org_study_id