Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Qadratus Lumborum Block
* Drug: 30 milliliters of 0.375% Ropivacaine
* Drug: 30 milliliters of 0.9% NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, placebo-controlled, randomised
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLB with 0,375% ropivacaine<br> | Procedure: Qadratus Lumborum Block<br>* Bilateral, ultrasound - guided Quadratus Lumborum Block<br>Drug: 30 milliliters of 0.375% Ropivacaine<br>* 30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block<br>|
| Placebo Comparator: QLB with 0,9% NaCl<br> | Procedure: Qadratus Lumborum Block<br>* Bilateral, ultrasound - guided Quadratus Lumborum Block<br>Drug: 30 milliliters of 0.9% NaCl<br>* 30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption following prostatectomy | Oxycodone consumption with Patient-Controlled Analgesia pump | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | 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. | 24 hours | 
| Time to first dose of opioid | Time in minutes from emergence from anesthesia to the first request for opioid | 24 hours | 
| Opioids - related complications | The occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic prostatectomy, regional anesthesia, quadratus lumborum block, patient controlled anesthesia