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Completed

NCT Number: NCT03600129

Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

Laparoscopic prostatectomy (LP) is characterized by substantial tissue trauma, despite its minimally -invasive approach. Although postoperative pain intensity is lower when compared to open procedures, the use of opioids is common. Retrospective review of available LP cases revealed that although analgesic demand varied, nearly all of our LP patients required opioids postoperatively. Bilateral Quadratus Lumborum Block (QLB), being one of relatively new features of regional anesthesia, offers good analgesia of abdominal wall, with the potential for control of visceral pain. This study was established to evaluate its effectiveness in alleviating pain after radical prostatectomy in a double - blind, placebo - controlled manner.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care

Warsaw, 01-813, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA status less or equal 3
  • Scheduled for transperitoneal or extraperitoneal endoscopic prostatectomy
  • Able to understand information provided and to sign the informed consent for participation in the study

Exclusion criteria

  • known allergy to local anesthetics and opioids
  • infection in the area of block placement
  • known chronic use of opioids, gabapentinoids and tricyclic antidepressants
  • mental inability to understand the principles and rules of patient-controlled analgesia pump

Treatment and study plan

Qadratus Lumborum Block

Procedure

Bilateral, ultrasound - guided Quadratus Lumborum Block

30 milliliters of 0.375% Ropivacaine

Drug

30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block

30 milliliters of 0.9% NaCl

Drug

30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block

Primary outcomes

  1. Opioid consumption following prostatectomy

    Time frame: 24 hours

    Oxycodone consumption with Patient-Controlled Analgesia pump

Secondary outcomes

  1. Pain score

    Time frame: 24 hours

    Pain scores assessed with Numeric Rating Scale (NRS).In this scale pain intensity is expressed using one of the numbers 0 - 10, 0 being no pain and 10 worst pain imaginable.

  2. Time to first dose of opioid

    Time frame: 24 hours

    Time in minutes from emergence from anesthesia to the first request for opioid

  3. Opioids - related complications

    Time frame: 24 hours

    The occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Control After Endoscopic Prostatectomy - Double Blinded, Placebo-controlled, Randomised Trial.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Oct 22, 2019

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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