Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Qadratus Lumborum Block
30 milliliters of 0.375% Ropivacaine
30 milliliters of 0.9% NaCl
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring regional anesthesia, quadratus lumborum block, patient controlled anesthesia, laparoscopic prostatectomy
Eligibility Criteria
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
Sites / Locations
- Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
QLB with 0,375% ropivacaine
QLB with 0,9% NaCl
Arm Description
Outcomes
Primary Outcome Measures
Opioid consumption following prostatectomy
Oxycodone consumption with Patient-Controlled Analgesia pump
Secondary Outcome Measures
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.
Time to first dose of opioid
Time in minutes from emergence from anesthesia to the first request for opioid
Opioids - related complications
The occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching
Full Information
NCT ID
NCT03600129
First Posted
July 12, 2018
Last Updated
October 21, 2019
Sponsor
Centre of Postgraduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT03600129
Brief Title
Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.
Official Title
Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Control After Endoscopic Prostatectomy - Double Blinded, Placebo-controlled, Randomised Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
October 21, 2019 (Actual)
Study Completion Date
October 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
regional anesthesia, quadratus lumborum block, patient controlled anesthesia, laparoscopic prostatectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, placebo-controlled, randomised
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Solution used for block (local anesthetic or placebo) is known to anesthetist not involved in patient's care.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QLB with 0,375% ropivacaine
Arm Type
Experimental
Arm Title
QLB with 0,9% NaCl
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Qadratus Lumborum Block
Intervention Description
Bilateral, ultrasound - guided Quadratus Lumborum Block
Intervention Type
Drug
Intervention Name(s)
30 milliliters of 0.375% Ropivacaine
Intervention Description
30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block
Intervention Type
Drug
Intervention Name(s)
30 milliliters of 0.9% NaCl
Intervention Description
30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block
Primary Outcome Measure Information:
Title
Opioid consumption following prostatectomy
Description
Oxycodone consumption with Patient-Controlled Analgesia pump
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain score
Description
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 Frame
24 hours
Title
Time to first dose of opioid
Description
Time in minutes from emergence from anesthesia to the first request for opioid
Time Frame
24 hours
Title
Opioids - related complications
Description
The occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching
Time Frame
24 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malgorzata Malec-Milewska, MD, PhD
Organizational Affiliation
Orlowski Hospital, Centre of Postgraduate Medical Education, Department of Anesthesiology and Intensive Care
Official's Role
Study Chair
Facility Information:
Facility Name
Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
City
Warsaw
ZIP/Postal Code
01-813
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.
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