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Completed

NCT Number: NCT05170373

ESP Block in Radical Prostatectomy

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.

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Key information

Age range

30 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESP block

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

Primary outcomes

  1. Numeric Pain Scale

    Time frame: postoperative 24 hours.

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

  2. Blood glucose

    Time frame: postoperative 24 hours.

    mg /dL

  3. insulin

    Time frame: postoperative 24 hours.

    µIU/mL

  4. cortisol

    Time frame: postoperative 24 hours.

    µg/dL

  5. prolactin

    Time frame: postoperative 24 hours.

    µg/L

  6. C-reactive protein

    Time frame: postoperative 24 hours.

    mg/L

Secondary outcomes

  1. Remifentanil Consumption Speed

    Time frame: 3 hours

    µg /kg/dk

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 28, 2021
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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