Pain, AcuteNCT03853460
Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy
A study testing epidural catheter and nerve block catheter in people with Pain, Acute, run by Assiut University at 2 sites in Egypt.
Trial summary
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- epidural catheter and nerve block catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Oct 2019to 30 Dec 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- elective surgery
- patients between 30 and 60 years
Who cannot join
- coagulopathy
- infection at insertion site
- patient refusal
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Assiut university
Asyut, 71111
rasha hamed, MD, 0882413201, amira_salem2015@yahoo.com
- Recruiting
Faculty of Medicine
Asyut, 71111
rasha hamed, 01000440773, rashaahmed11@yahoo.com
saeed elsawy, 01030072161, saeedelsawy17@gmail.com
About this study
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.
Read the detailed description
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.
- Conditions
- Pain, Acute
- Being tested
- epidural catheter, nerve block catheter
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheterProcedure or surgery
ultrasound low frequency probe will be used to determine the depth of the posterior complex to assists placement of midline thoracic epidural
nerve block catheterProcedure or surgery
ultrasound guided placement of bilateral quadratus lumborum catheters
| Study group | Role | What they receive |
|---|---|---|
| epidural group | Active comparator | ULTRASOUND GUIDED thoracic epidural at T 12 WILL BE INSERTED before anaesthesia induction Receives: Procedure: epidural catheter |
| quadus lumborum group | Active comparator | bilateral ultrasound guided quadratus lumborum catheter will be inserted before anaesthesia induction Receives: Procedure: nerve block catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Visual analogue score from 0 to 10 will be used to assess pain postoperative. 0 means no pain. 10 is worst pain
Measured: 24 hours
Secondary outcomes (2)
anaesthetic consumption
calculating the total anaesthetic MAC consumed
Measured: 4 hours
diaphragmatic excursion
assessment of diaphragmatic excursion preoperative and postoperative using low frequency ultrasound probe
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 posted25 Feb 2019
- Study start30 Oct 2019
- Primary completion30 May 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853460
- Sponsor's protocol ID
- QLMD
- Status last verified
- Nov 2019
- First submitted
- 20 Feb 2019
- Last updated
- 5 Nov 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 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy
- ClinicalTrials.gov ID
- NCT03853460
- Acronym / sponsor ID
- QLMD
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 25 Feb 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.
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.
Detailed description
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural group | Active comparator | Procedure: epidural catheterULTRASOUND GUIDED thoracic epidural at T 12 WILL BE INSERTED before anaesthesia induction |
| quadus lumborum group | Active comparator | Procedure: nerve block catheterbilateral ultrasound guided quadratus lumborum catheter will be inserted before anaesthesia induction |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- elective surgery
- patients between 30 and 60 years
Key exclusion criteria (3 listed)
- coagulopathy
- infection at insertion site
- patient refusal
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 |
|---|---|---|
| epidural catheterultrasound low frequency probe will be used to determine the depth of the posterior complex to assists placement of midline thoracic epidural | Procedure or surgery | epidural group |
| nerve block catheterultrasound guided placement of bilateral quadratus lumborum catheters | Procedure or surgery | quadus lumborum group |
Primary outcome
pain score
Time frame: 24 hours
Visual analogue score from 0 to 10 will be used to assess pain postoperative. 0 means no pain. 10 is worst pain
2 secondary outcomes
anaesthetic consumption
Time frame: 4 hours
diaphragmatic excursion
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural catheter and nerve block catheter in people with Pain, Acute, run by Assiut University at 2 sites 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 3 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (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 5 Nov 2019.