Postoperative PainQLBIINCT03941899
The Analgesic Effect of QLB II After Robotic Prostatectomy. (QLB II: Quadratus Lomborum Block II Type)
A study testing Levobupivacaine in QLB II in people with Postoperative Pain, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
Trial summary
The analgesic effects of Quadratus Lomborum Block II type after robotic-assisted laparoscopic radical prostatectomy, will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Levobupivacaine in QLB II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2019to 30 Apr 2021
- 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 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist status I-III
- Written informed consent
Who cannot join
- Body mass Index > 35 kg/m2
- Allergies to local anesthetics
- primaries or secondaries coagulopathies
- addiction to drugs
- severe kidney and liver diseases
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Effect of Qudratus Lomborum Block II Type After Robotic-Assisted Laparoscopic Radical Prostatectomy.
The analgesic effects of Quadratus Lomborum Block II type after robotic-assisted laparoscopic radical prostatectomy, will be assessed.
Read the detailed description
Quadratus Lomborum Block II type will be performed before performing robotic-assisted laparoscopic radical prostatectomy.
The post-operative analgesic effect will be assessed, by using Numeric Rate Scale for pain.
The pain assessment will be evaluated during the first 24 hours from surgery. The opioids requirement and side effects will be also assessed.
- Conditions
- Postoperative Pain
- Being tested
- Levobupivacaine in QLB II
- Keywords
- Pain, radical prostatectomy, QLB II type
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine in QLB IIOther
Also called Quadratus Lomborum Block II type
Quadratus Lomborum Block II type will be performed by injecting levobupivacaine 0.375% 20 ml between latissimus dorsi and quadratus lomborum muscle.
| Study group | Role | What they receive |
|---|---|---|
| QLB II | Other | Quadratus Lomborum Blocck II type will be performed before robot-assisted laparoscopic radical prostatectomy Receives: Other: Levobupivacaine in QLB II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia
Pain assessment by using Numeric Rate Scale for pain
Measured: The first 24 hours from surgery
Secondary outcomes (4)
Opioids
The opioids requirement (mg of equianalgesic morphine) will be assessed
Measured: The first 24 hours from surgery
Postoperative Nausea and Vomiting
The postoperative nausea and vomiting will be assessed
Measured: The first 24 hours from surgery
Bowel function
The recovery of bowel function will be assessed
Measured: The first 24 hours from surgery
Length of stay
The length of stay after surgery will be assessed
Measured: Day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start6 May 2019
- Primary completion6 Dec 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simon's Two-Stage single arm study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Salvatore Hospital of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Franco Marinangeli, MD, Study chair, San Salvatore Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941899
- Sponsor's protocol ID
- 0081052
- Acronym
- QLBII
- Status last verified
- May 2021
- First submitted
- 6 May 2019
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Qudratus Lomborum Block II Type After Robotic-Assisted Laparoscopic Radical Prostatectomy.
- ClinicalTrials.gov ID
- NCT03941899
- Acronym / sponsor ID
- QLBII / 0081052
- Conditions
- Postoperative Pain
- Keywords
- Pain, radical prostatectomy, QLB II type
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 May 2019 (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.
The analgesic effects of Quadratus Lomborum Block II type after robotic-assisted laparoscopic radical prostatectomy, will be assessed.
Detailed description
Quadratus Lomborum Block II type will be performed before performing robotic-assisted laparoscopic radical prostatectomy.
The post-operative analgesic effect will be assessed, by using Numeric Rate Scale for pain.
The pain assessment will be evaluated during the first 24 hours from surgery. The opioids requirement and side effects will be also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's Two-Stage single arm study
| Arm | Type | Receives |
|---|---|---|
| QLB II | Other | Other: Levobupivacaine in QLB IIQuadratus Lomborum Blocck II type will be performed before robot-assisted laparoscopic radical prostatectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist status I-III
- Written informed consent
Key exclusion criteria (6 listed)
- Body mass Index > 35 kg/m2
- Allergies to local anesthetics
- primaries or secondaries coagulopathies
- addiction to drugs
- severe kidney and liver diseases
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 |
|---|---|---|
| Levobupivacaine in QLB IIAlso: Quadratus Lomborum Block II typeQuadratus Lomborum Block II type will be performed by injecting levobupivacaine 0.375% 20 ml between latissimus dorsi and quadratus lomborum muscle. | Other | QLB II |
Primary outcome
Analgesia
Time frame: The first 24 hours from surgery
Pain assessment by using Numeric Rate Scale for pain
4 secondary outcomes
Opioids
Time frame: The first 24 hours from surgery
Postoperative Nausea and Vomiting
Time frame: The first 24 hours from surgery
Bowel function
Time frame: The first 24 hours from surgery
Length of stay
Time frame: Day after surgery
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 4 May 2021.
- 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.
Franco Marinangeli, MD study chair
San Salvatore Academic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine in QLB II in people with Postoperative Pain, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
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 2 inclusion and 6 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 4 May 2021. 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 Italy. 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. 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?
Analgesia (time frame: The first 24 hours from surgery). 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 4 May 2021.