AnalgesiaNCT04800302
U/S-guided Continuous Quadratus Lumborum Block III in Percutaneous Nephrolithotomy
A study testing Continous Quadratum Lumborum Block III, Single dose Quadratum Lumborum Block III and Intra-venous Morphine in people with Analgesia and Surgery, run by Nazmy Edward Seif at 1 site in Egypt.
Trial summary
Percutaneous nephrolithotomy (PCNL) is considered to be the first choice and a more conservative procedure than open stone surgery. Not only postoperative pain related to dilatation of the renal capsule and parenchymal tract, but also patient's discomfort \& nephrostomy tube-related stress are reported to delay… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Surgery, Renal Stone
- What is being tested?
- Continous Quadratum Lumborum Block III, Single dose Quadratum Lumborum Block III and Intra-venous Morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2021to 28 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II.
- Scheduled for percutaneous nephrolithotomy (PCNL).
Who cannot join
- Patient refusal.
- Coagulation disorders.
- Skin lesions or infection at site of needle insertion.
- Known allergy to local anesthetics or opioids.
- Patients suffering from neurological or mental disease.
- Procedure turned into open stone surgery.
Show all 9Show fewer
- Failure of identification by U/S.
- Urinary tract malignancies.
- Opioid consumption 48 hours before the operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Continuous Quadratus Lumborum Block III for Postoperative Analgesia in Percutaneous Nephrolithotomy
Percutaneous nephrolithotomy (PCNL) is considered to be the first choice and a more conservative procedure than open stone surgery. Not only postoperative pain related to dilatation of the renal capsule and parenchymal tract, but also patient's discomfort \& nephrostomy tube-related stress are reported to delay recovery time and increase the complication rates. This study is designed to provide postoperative analgesia by using ultrasound-guided continuous Quadratus Lumborum Block (QLB) III in patients undergoing PCNL and to assess pain scores \& side effects with less opioids consumption.
- Conditions
- Analgesia, Surgery, Renal Stone
- Being tested
- Continous Quadratum Lumborum Block III, Single dose Quadratum Lumborum Block III, Intra-venous Morphine
- Keywords
- Quadratus Lumborum Block III, Ultrasound-guided, Percutaneous nephrolithotomy, Analgesia
- Medical subject headings
- Agnosia, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous Quadratum Lumborum Block IIIProcedure or surgery
Continuous infusion of Bupivacaine 0.125 % at a rate of 0.1 ml/kg/hr (not exceeding 12 ml/hour), infused through a catheter inserted in the plane between quadratus lumborum \& psoas major muscles with ultrasound guidance.
Single dose Quadratum Lumborum Block IIIProcedure or surgery
Single injection of a mixture solution of 20 ml Bupivacaine 0.5% + 10 ml Lidocaine 2%, injected through a needle inserted at the posterior aspect of the quadratus lumborum muscle between it and erector spinae muscle with ultrasound guidance.
Intra-venous MorphineProcedure or surgery
Intra-venous Morphine [0.1 mg/kg] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4.
| Study group | Role | What they receive |
|---|---|---|
| Continuous QLB group | Experimental | U/S-guided continous QLB III Receives: Procedure: Continous Quadratum Lumborum Block III; Procedure: Single dose Quadratum Lumborum Block III; Procedure: Intra-venous Morphine |
| Single dose QLB group | Active comparator | U/S-guided single dose QLB III Receives: Procedure: Single dose Quadratum Lumborum Block III; Procedure: Intra-venous Morphine |
| Morphine group | Active comparator | IV Morphine Receives: Procedure: Intra-venous Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption.
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
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 posted16 Mar 2021
- Study start10 Jun 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Sherif A Embaby, MSc, Principal investigator, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800302
- Sponsor's protocol ID
- USGCQLBIIIPCNL
- Status last verified
- Jul 2022
- First submitted
- 12 Mar 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Continuous Quadratus Lumborum Block III for Postoperative Analgesia in Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT04800302
- Acronym / sponsor ID
- USGCQLBIIIPCNL
- Conditions
- Analgesia, Surgery, Renal Stone
- Keywords
- Quadratus Lumborum Block III, Ultrasound-guided, Percutaneous nephrolithotomy, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 16 Mar 2021 (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.
Percutaneous nephrolithotomy (PCNL) is considered to be the first choice and a more conservative procedure than open stone surgery. Not only postoperative pain related to dilatation of the renal capsule and parenchymal tract, but also patient's discomfort \& nephrostomy tube-related stress are reported to delay recovery time and increase the complication rates. This study is designed to provide postoperative analgesia by using ultrasound-guided continuous Quadratus Lumborum Block (QLB) III in patients undergoing PCNL and to assess pain scores \& side effects with less opioids consumption.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous QLB group | Experimental | Procedure: Continous Quadratum Lumborum Block III, Procedure: Single dose Quadratum Lumborum Block III, Procedure: Intra-venous MorphineU/S-guided continous QLB III |
| Single dose QLB group | Active comparator | Procedure: Single dose Quadratum Lumborum Block III, Procedure: Intra-venous MorphineU/S-guided single dose QLB III |
| Morphine group | Active comparator | Procedure: Intra-venous MorphineIV Morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II.
- Scheduled for percutaneous nephrolithotomy (PCNL).
Key exclusion criteria (9 listed)
- Patient refusal.
- Coagulation disorders.
- Skin lesions or infection at site of needle insertion.
- Known allergy to local anesthetics or opioids.
- Patients suffering from neurological or mental disease.
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 |
|---|---|---|
| Continous Quadratum Lumborum Block IIIContinuous infusion of Bupivacaine 0.125 % at a rate of 0.1 ml/kg/hr (not exceeding 12 ml/hour), infused through a catheter inserted in the plane between quadratus lumborum \& psoas major muscles with ultrasound guidance. | Procedure or surgery | Continuous QLB group |
| Single dose Quadratum Lumborum Block IIISingle injection of a mixture solution of 20 ml Bupivacaine 0.5% + 10 ml Lidocaine 2%, injected through a needle inserted at the posterior aspect of the quadratus lumborum muscle between it and erector spinae muscle with ultrasound guidance. | Procedure or surgery | Continuous QLB group, Single dose QLB group |
| Intra-venous MorphineIntra-venous Morphine [0.1 mg/kg] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4. | Procedure or surgery | Continuous QLB group, Morphine group, Single dose QLB group |
Primary outcome
Morphine consumption.
Time frame: 24 hours
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
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 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Sherif A Embaby, MSc principal investigator
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continous Quadratum Lumborum Block III, Single dose Quadratum Lumborum Block III and Intra-venous Morphine in people with Analgesia and Surgery, run by Nazmy Edward Seif at 1 site in Egypt.
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 9 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 Jul 2022. 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 Egypt. 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?
Morphine consumption. (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 Jul 2022.