Prostate CancerNCT03600129
Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.
A study testing Qadratus Lumborum Block, 30 milliliters of 0.375% Ropivacaine and 30 milliliters of 0.9% NaCl in people with Prostate Cancer, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Qadratus Lumborum Block, 30 milliliters of 0.375% Ropivacaine and 30 milliliters of 0.9% NaCl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 25 Jul 2018to 21 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
Warsaw, 01-813
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Qadratus Lumborum Block, 30 milliliters of 0.375% Ropivacaine, 30 milliliters of 0.9% NaCl
- Keywords
- regional anesthesia, quadratus lumborum block, patient controlled anesthesia, laparoscopic prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qadratus Lumborum BlockProcedure or surgery
Bilateral, ultrasound - guided Quadratus Lumborum Block
30 milliliters of 0.375% RopivacaineDrug
30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block
30 milliliters of 0.9% NaClDrug
30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block
| Study group | Role | What they receive |
|---|---|---|
| QLB with 0,375% ropivacaine | Experimental | Not described Receives: Procedure: Qadratus Lumborum Block; Drug: 30 milliliters of 0.375% Ropivacaine |
| QLB with 0,9% NaCl | Placebo comparator | Not described Receives: Procedure: Qadratus Lumborum Block; Drug: 30 milliliters of 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption following prostatectomy
Oxycodone consumption with Patient-Controlled Analgesia pump
Measured: 24 hours
Secondary outcomes (3)
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.
Measured: 24 hours
Time to first dose of opioid
Time in minutes from emergence from anesthesia to the first request for opioid
Measured: 24 hours
Opioids - related complications
The occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start25 Jul 2018
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, placebo-controlled, randomised
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Horosz, MD, Centre of Postgraduate Medical Education
- Investigators
- Malgorzata Malec-Milewska, MD, PhD, Study chair, Orlowski Hospital, Centre of Postgraduate Medical Education, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600129
- Sponsor's protocol ID
- 83/PB/2018
- Status last verified
- Oct 2019
- First submitted
- 12 Jul 2018
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Control After Endoscopic Prostatectomy - Double Blinded, Placebo-controlled, Randomised Trial.
- ClinicalTrials.gov ID
- NCT03600129
- Acronym / sponsor ID
- 83/PB/2018
- Conditions
- Prostate Cancer
- Keywords
- regional anesthesia, quadratus lumborum block, patient controlled anesthesia, laparoscopic prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, placebo-controlled, randomised
| Arm | Type | Receives |
|---|---|---|
| QLB with 0,375% ropivacaine | Experimental | Procedure: Qadratus Lumborum Block, Drug: 30 milliliters of 0.375% Ropivacaine |
| QLB with 0,9% NaCl | Placebo comparator | Procedure: Qadratus Lumborum Block, Drug: 30 milliliters of 0.9% NaCl |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qadratus Lumborum BlockBilateral, ultrasound - guided Quadratus Lumborum Block | Procedure or surgery | QLB with 0,375% ropivacaine, QLB with 0,9% NaCl |
| 30 milliliters of 0.375% Ropivacaine30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block | Drug | QLB with 0,375% ropivacaine |
| 30 milliliters of 0.9% NaCl30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block | Drug | QLB with 0,9% NaCl |
Primary outcome
Opioid consumption following prostatectomy
Time frame: 24 hours
Oxycodone consumption with Patient-Controlled Analgesia pump
3 secondary outcomes
Pain score
Time frame: 24 hours
Time to first dose of opioid
Time frame: 24 hours
Opioids - related complications
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malgorzata Malec-Milewska, MD, PhD study chair
Orlowski Hospital, Centre of Postgraduate Medical Education, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qadratus Lumborum Block, 30 milliliters of 0.375% Ropivacaine and 30 milliliters of 0.9% NaCl in people with Prostate Cancer, run by Centre of Postgraduate Medical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption following prostatectomy (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.