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Clinical Trials/NCT05170373
NCT05170373
Completed
Not Applicable

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

Istanbul Medeniyet University1 site in 1 country46 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erector Spinae Plane Block
Sponsor
Istanbul Medeniyet University
Enrollment
46
Locations
1
Primary Endpoint
prolactin
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
June 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Istanbul Medeniyet University
Responsible Party
Principal Investigator
Principal Investigator

Damla Turan

Principal Investigator

Istanbul Medeniyet University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

prolactin

Time Frame: postoperative 24 hours.

µg/L

cortisol

Time Frame: postoperative 24 hours.

µg/dL

Numeric Pain Scale

Time Frame: postoperative 24 hours.

Between 1-10. 1: no pain, 10: worst possible pain

insulin

Time Frame: postoperative 24 hours.

µIU/mL

C-reactive protein

Time Frame: postoperative 24 hours.

mg/L

Blood glucose

Time Frame: postoperative 24 hours.

mg /dL

Secondary Outcomes

  • Remifentanil Consumption Speed(3 hours)

Study Sites (1)

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