ESP Block in Radical Prostatectomy

Effects of Ultrasound Guided Erector Spinae Plane Block in Radical Prostatectomy Surgery on Pain and Surgical Stress Response

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.

Study Overview

• Status: Completed
• Conditions: Erector Spinae Plane Block
• Intervention / Treatment: Procedure: ESP block

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Suleyman Yalcin City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group
ACTIVE_COMPARATOR: ESP group	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Scale	Between 1-10. 1: no pain, 10: worst possible pain	postoperative 24 hours.
Blood glucose	mg /dL	postoperative 24 hours.
insulin	µIU/mL	postoperative 24 hours.
cortisol	µg/dL	postoperative 24 hours.
prolactin	µg/L	postoperative 24 hours.
C-reactive protein	mg/L	postoperative 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanil Consumption Speed	µg /kg/dk	3 hours

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (ACTUAL): December 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative Analgesia; Erektor Spinae Plane Block; Surgical Stress Response
• Other Study ID Numbers: IstanbulMU ESPB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No