Postoperative PainNCT04215705
Quadratus Lumborum Block III Versus Peritubal Local Infiltration
A study testing Quadratus block versus peritubal local infiltration in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Investigators compare post operative analgesic efficacy of peritubal local infiltration versus Quadratus Lumborum Block III . In patients undergoing Percutaneous Nephrolithotomy operation Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Quadratus block versus peritubal local infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2019to 15 Jul 2020
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient with pelvic renal stone less than 2 cm
- Americans society of Anesthesiologists physical status I, II
- BMI<35
Who cannot join
- patient refusal to participate in the study
- Americans society of Anesthesiologists physical status III or above
- major hepatic, renal or cardiovascular disease
- BMI > 35
- coagulopathy
- psychological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesic Efficiency of Quadratus Lumborum Block III Versus Peritubal Local Infiltration in Patients Undergoing exPercutaneous Percutaneous Nephrolithotomy Operation : a Randomized Comparative Study
Investigators compare post operative analgesic efficacy of peritubal local infiltration versus Quadratus Lumborum Block III . In patients undergoing Percutaneous Nephrolithotomy operation
- Conditions
- Postoperative Pain
- Being tested
- Quadratus block versus peritubal local infiltration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus block versus peritubal local infiltrationProcedure or surgery
Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation
| Study group | Role | What they receive |
|---|---|---|
| Group Q | Active comparator | Patients in this group receive Quadratus Lumborum Block with 20 ml bupivacaine 0.5% Receives: Procedure: Quadratus block versus peritubal local infiltration |
| Group L | Active comparator | Patients in this group receive peritubal local infiltration at 6 and 12 o'clock position with 20ml bupivacaine 0.5% Receives: Procedure: Quadratus block versus peritubal local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Postoperative pain measured by visual analogue scale from 0 to 10 measured over 24h where 0 is better and 10 means worst pain
Measured: 24 hours
Analgesic requirement
Investigators measured the total dose of morphine consumption in mg over 24hour
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 posted2 Jan 2020
- Study start30 Dec 2019
- Primary completion12 Jul 2020
- Study completion15 Jul 2020
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.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, simon Halim Armanious, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215705
- Sponsor's protocol ID
- Post PCNL analgesia
- Status last verified
- Nov 2020
- First submitted
- 28 Dec 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request from Corresponding Author
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficiency of Quadratus Lumborum Block III Versus Peritubal Local Infiltration in Patients Undergoing exPercutaneous Percutaneous Nephrolithotomy Operation : a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04215705
- Acronym / sponsor ID
- Post PCNL analgesia
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 12 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 2 Jan 2020 (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.
Investigators compare post operative analgesic efficacy of peritubal local infiltration versus Quadratus Lumborum Block III . In patients undergoing Percutaneous Nephrolithotomy operation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Q | Active comparator | Procedure: Quadratus block versus peritubal local infiltrationPatients in this group receive Quadratus Lumborum Block with 20 ml bupivacaine 0.5% |
| Group L | Active comparator | Procedure: Quadratus block versus peritubal local infiltrationPatients in this group receive peritubal local infiltration at 6 and 12 o'clock position with 20ml bupivacaine 0.5% |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient with pelvic renal stone less than 2 cm
- Americans society of Anesthesiologists physical status I, II
- BMI<35
Key exclusion criteria (6 listed)
- patient refusal to participate in the study
- Americans society of Anesthesiologists physical status III or above
- major hepatic, renal or cardiovascular disease
- BMI > 35
- coagulopathy
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 |
|---|---|---|
| Quadratus block versus peritubal local infiltrationQuadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation | Procedure or surgery | Group L, Group Q |
Primary outcome
Postoperative analgesia
Time frame: 24 hours
Postoperative pain measured by visual analogue scale from 0 to 10 measured over 24h where 0 is better and 10 means worst pain
Analgesic requirement
Time frame: 24 hours
Investigators measured the total dose of morphine consumption in mg over 24hour
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 6 Nov 2020.
- Individual participant dataSharing planned: Yes. Upon request from Corresponding Author
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus block versus peritubal local infiltration in people with Postoperative Pain, run by Ain Shams University 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 3 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 6 Nov 2020. 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?
Postoperative analgesia (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 6 Nov 2020.