Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Qadratus Lumborum Block; Drug: 30 milliliters of 0.375% Ropivacaine; Drug: 30 milliliters of 0.9% NaCl

• Registration Number: NCT03600129
• Lead Sponsor: Centre of Postgraduate Medical Education

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-24
• Study Start: 2018-07-25
• Study First Posted: 2018-07-26
• Status Verified: 2019-10
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLB with 0,375% ropivacaine	30 milliliters of 0.375% Ropivacaine	-
QLB with 0,9% NaCl	Qadratus Lumborum Block	-
QLB with 0,9% NaCl	30 milliliters of 0.9% NaCl	-
QLB with 0,375% ropivacaine	Qadratus Lumborum Block	-

Primary Outcome Measures

Name	Time	Method
Opioid consumption following prostatectomy	24 hours	Oxycodone consumption with Patient-Controlled Analgesia pump

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care; 🇵🇱 Warsaw, Poland