Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

October 21, 2019 updated by: Bartosz Horosz, MD, Centre of Postgraduate Medical Education

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-813
        • Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre of Postgraduate Medical Education

Investigators

  • Study Chair: Malgorzata Malec-Milewska, MD, PhD, Orlowski Hospital, Centre of Postgraduate Medical Education, Department of Anesthesiology and Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2018

Primary Completion (Actual)

October 21, 2019

Study Completion (Actual)

October 21, 2019

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83/PB/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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