ESP Block in Radical Prostatectomy

Erector Spinae Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170373
• Other study ID #: IstanbulMU ESPB
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2021
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Suleyman Yalcin City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Scale	Between 1-10. 1: no pain, 10: worst possible pain	postoperative 24 hours.
Primary	Blood glucose	mg /dL	postoperative 24 hours.
Primary	insulin	µIU/mL	postoperative 24 hours.
Primary	cortisol	µg/dL	postoperative 24 hours.
Primary	prolactin	µg/L	postoperative 24 hours.
Primary	C-reactive protein	mg/L	postoperative 24 hours.
Secondary	Remifentanil Consumption Speed	µg /kg/dk	3 hours