Percutaneous NephrolithotomyPhase 4NCT04196270
The Minimal Effective Volume (MEV90) of Ropivacaine 0.75% for Ultrasound-guided Transmuscular Quadratus Lumborum Block
A Phase 4 study testing Ropivacaine injection in people with Percutaneous Nephrolithotomy, run by Zealand University Hospital.
Trial summary
This double-blind dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anesthetic administered to each patient depends on the response from the previous one. The TQL block is performed preoperatively, and the first patient recruited receives 20 mL of ropivacaine 0.75%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2020to 1 Nov 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for the trail must comply with all of the following requirements to be included:
- Scheduled for elective PNL surgery in general anesthesia with propofol and remifentanil
- Age > 18 years at the date of inclusion
- Have received thorough information, oral and written, and signed the "informed consent" form on participation in the trail
- ASA score 1-3
Who cannot join
- Inability to speak and understand Danish
- Allergy to local anesthetics or opioids
- Daily intake of opioids (evaluated by the investigators)
- Drug and/or substance abuse
- Local infection at the site of injection or systemic infection
- Difficult visualization of muscular and fascial structures necessary for successful block administration
- Pregnancy or breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Minimal Effective Volume (MEV90) of Ropivacaine 0.75% for Ultrasound-guided Transmuscular Quadratus Lumborum Block for Unilateral Percutaneous Nephrolitotomy: a Study Protocol for a Dose Finding Trial
This double-blind dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anesthetic administered to each patient depends on the response from the previous one. The TQL block is performed preoperatively, and the first patient recruited receives 20 mL of ropivacaine 0.75%. In case of block failure, the next patient will receive a higher volume (defined as the previous volume with an increment of 2 mL). Given a successful block for the first patient, the next patient will be randomized to either a lower volume (defined as the previous volume with a reduction of 2 mL) or the same volume as the previous patient. The respective probabilities being b=0.11 for a reduced volume and 1-b=0.89 for the same volume. Block success is defined as patient reported numeric rated scale (NRS) pain (NRS value ≤ 3 (0-10/10)), 30 minutes after arrival in the post anesthesia care unit (PACU). The NRS pain value is our primary and only outcome in the evaluation of the block. A minimum of 25 eligible patients are needed to achieve precise estimation of MEV90 with narrow 95% confidence intervals derived by bootstrapping. Following inclusion of 25 patients early termination is considered when interim analysis shows sufficiently stabilization of MEV90 estimate. The final sample size is not known a priori, but a maximum of 40 patients will be enrolled in the trial.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Ropivacaine injection
- Keywords
- dose finding study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Also called Sequential design
In a dose finding study the total volume of ropivacaine changes according to the biased coin up-and-down sequential design
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | This double-blind dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anesthetic administered to each patient depends on the response from the previous one. The TQL block is performed preoperatively, and the first patient recruited receives 20 mL of ropivacaine 0.75%. In case of block failure, the next patient will receive a higher volume (defined as the previous volume with an increment of 2 mL). Given a successful block for the first patient, the next patient will be randomized to either a lower volume (defined as the previous volume with a reduction of 2 mL) or the same volume as the previous patient. The respective probabilities being b=0.11 for a reduced volume and 1-b=0.89 for the same volume. Block success is defined as patient reported numeric rated scale (NRS) pain (NRS value ≤ 3 (0-10/10)), 30 minutes after arrival in the post anesthesia care unit (PACU). Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rated scale
Pain score from numeric rated scale 0-10/10 Pain score, numeric rated scale 0-10/10. 0=no pain, 10=maximum pain
Measured: 30 minutes after arrival in the post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start5 Jan 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Model description
- The biased coin up-and-down sequential design (BCD) should be considered for direct determination of higher quantiles (ED90 and ED95) which provide useful clinical knowledge. The BCD was developed in the field of pharmacology and toxicology and was formulated by Durham et al. in 1997. In the BCD, volume assignment is carried out in a sequential and interactive method, which avoids that patients are randomized to doses with toxicity risk and seeks to concentrate treatments around the suitable doses.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196270
- Sponsor's protocol ID
- Clinical Trials Zealand
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 16 Dec 2019
- 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 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minimal Effective Volume (MEV90) of Ropivacaine 0.75% for Ultrasound-guided Transmuscular Quadratus Lumborum Block for Unilateral Percutaneous Nephrolitotomy: a Study Protocol for a Dose Finding Trial
- ClinicalTrials.gov ID
- NCT04196270
- Acronym / sponsor ID
- Clinical Trials Zealand
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- dose finding study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 12 Dec 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.
This double-blind dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anesthetic administered to each patient depends on the response from the previous one. The TQL block is performed preoperatively, and the first patient recruited receives 20 mL of ropivacaine 0.75%. In case of block failure, the next patient will receive a higher volume (defined as the previous volume with an increment of 2 mL). Given a successful block for the first patient, the next patient will be randomized to either a lower volume (defined as the previous volume with a reduction of 2 mL) or the same volume as the previous patient. The respective probabilities being b=0.11 for a reduced volume and 1-b=0.89 for the same volume. Block success is defined as patient reported numeric rated scale (NRS) pain (NRS value ≤ 3 (0-10/10)), 30 minutes after arrival in the post anesthesia care unit (PACU). The NRS pain value is our primary and only outcome in the evaluation of the block. A minimum of 25 eligible patients are needed to achieve precise estimation of MEV90 with narrow 95% confidence intervals derived by bootstrapping. Following inclusion of 25 patients early termination is considered when interim analysis shows sufficiently stabilization of MEV90 estimate. The final sample size is not known a priori, but a maximum of 40 patients will be enrolled in the trial.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The biased coin up-and-down sequential design (BCD) should be considered for direct determination of higher quantiles (ED90 and ED95) which provide useful clinical knowledge. The BCD was developed in the field of pharmacology and toxicology and was formulated by Durham et al. in 1997. In the BCD, volume assignment is carried out in a sequential and interactive method, which avoids that patients are randomized to doses with toxicity risk and seeks to concentrate treatments around the suitable doses.
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: Ropivacaine injectionThis double-blind dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anesthetic administered to each patient depends on the response from the previous one. The TQL block is performed preoperatively, and the first patient recruited receives 20 mL of ropivacaine 0.75%. In case of block failure, the next patient will receive a higher volume (defined as the previous volume with an increment of 2 mL). Given a successful block for the first patient, the next patient will be randomized to either a lower volume (defined as the previous volume with a reduction of 2 mL) or the same volume as the previous patient. The respective probabilities being b=0.11 for a reduced volume and 1-b=0.89 for the same volume. Block success is defined as patient reported numeric rated scale (NRS) pain (NRS value ≤ 3 (0-10/10)), 30 minutes after arrival in the post anesthesia care unit (PACU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients eligible for the trail must comply with all of the following requirements to be included:
Key exclusion criteria (7 listed)
- Inability to speak and understand Danish
- Allergy to local anesthetics or opioids
- Daily intake of opioids (evaluated by the investigators)
- Drug and/or substance abuse
- Local infection at the site of injection or systemic infection
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 |
|---|---|---|
| Ropivacaine injectionAlso: Sequential designIn a dose finding study the total volume of ropivacaine changes according to the biased coin up-and-down sequential design | Drug | Ropivacaine |
Primary outcome
Numeric rated scale
Time frame: 30 minutes after arrival in the post anesthesia care unit
Pain score from numeric rated scale 0-10/10 Pain score, numeric rated scale 0-10/10. 0=no pain, 10=maximum pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine injection in people with Percutaneous Nephrolithotomy, run by Zealand University Hospital.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens B Børglum, PhD (+4530700120, jens.borglum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rated scale (time frame: 30 minutes after arrival in the post anesthesia care unit). 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 16 Dec 2019.