Quadratus Lumborum BlockNCT05089994
Comparison of Two Approaches of Quadratus Lumborum Block for Post-operative Analgesia in Radical Cystectomy
A study testing US guided injection in people with Quadratus Lumborum Block, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the postoperative analgesic effect of two ultrasound guided approaches of quadratus lumborum block (QLB) (anterior and intramuscular) for radical cystectomy. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Quadratus Lumborum Block
- What is being tested?
- US guided injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2021to 25 Sep 2024
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40-70years.
- BMI: 20-30 kg.m2
- Sex: both males and females.
- American Society of Anesthesiologists (ASA )physical status: I-III.
- Operation: radical cystectomy
Who cannot join
- • Patient's refusal to participate in the study.
- known allergy to local anesthesia (LA),
- coagulopathy or thrombocytopenia,
- body mass index (BMI) above 30 kg .m 2, and infection at site of injection.
- Chronic pain syndromes,
- Prolonged opioid medication,
- Patients on regular use of analgesic or who received analgesic 24 h before surgery
Trial locations and contacts
1 site in 1 country.
Abdel raheem Mahmoud Mohamed, Prof contact
Egypt1 site, 1 recruiting
- Recruiting
Assuit university urology hospital
Asyut
Hassan Mostafa abdelbaky, 01060264751, Hassan.mostafa9444@gmail.com
About this study
Official title: Comparison of Two Approaches of Quadratus Lumborum Block for Post-operative Analgesia in Radical Cystectomy: Prospective-randomized Clinical Trial
To compare the postoperative analgesic effect of two ultrasound guided approaches of quadratus lumborum block (QLB) (anterior and intramuscular) for radical cystectomy.
Read the detailed description
The quadratus lumborum block (QLB) is one of the abdominal wall block techniques used to anesthetize thoracolumbar nerves . The QLB technique was described initially by Blanco et al. in 2007 (not published), then reported initially by Kadam in 2013. Since then, QLB has evolved with the development of the ultrasound-guided nerve block. To date, several randomized controlled trials have reported effective postoperative analgesia, with non-intramuscular QLB for cesarean sections, laparoscopic gynecologic surgery and hip hemiarthroplasty .
The intramuscular QLB (QLBi) technique was first reported by. This approach is different from others in tubouchi for QLB; although the injection target sites of the other approaches are planes around the quadratus lumborum muscle, the intramuscular approach penetrates the fascia of the quadratus lumborum muscle, where local anesthetics are injected. Therefore, QLBi is relatively easier to perform compared with other QLB approaches.
The incidence of urinary bladder cancer in the Middle East and Africa is greater in areas with high rather than low SH prevalence.
- Conditions
- Quadratus Lumborum Block
- Being tested
- US guided injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided injectionProcedure or surgery
using 2.5mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , received ultrasound-guided quadratus lumborum.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (QLBA) will include 30 patients | Experimental | will receive ultrasound-guided anterior approach quadratus lumborum block Receives: Procedure: US guided injection |
| Group 2 (QLBI)will include 30 patients. | Experimental | received ultrasound-guided intramuscular quadratus lumborum. Receives: Procedure: US guided injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the first call for rescue analgesia
The time of the first call of analgesia is recorded
Measured: 24hours after recovery From anesthesia
Secondary outcomes (1)
Total doses of morphine required
Doses of morphine required postoperative
Measured: 24hours after recovery from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start6 Oct 2021
- Primary completion4 Sep 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus Lumborum BlockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan mostafa abdelbaky ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089994
- Sponsor's protocol ID
- 01060264751
- Status last verified
- Jun 2024
- First submitted
- 22 May 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Approaches of Quadratus Lumborum Block for Post-operative Analgesia in Radical Cystectomy: Prospective-randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05089994
- Acronym / sponsor ID
- 01060264751
- Conditions
- Quadratus Lumborum Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 4 Sep 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 22 Oct 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.
To compare the postoperative analgesic effect of two ultrasound guided approaches of quadratus lumborum block (QLB) (anterior and intramuscular) for radical cystectomy.
Detailed description
The quadratus lumborum block (QLB) is one of the abdominal wall block techniques used to anesthetize thoracolumbar nerves . The QLB technique was described initially by Blanco et al. in 2007 (not published), then reported initially by Kadam in 2013. Since then, QLB has evolved with the development of the ultrasound-guided nerve block. To date, several randomized controlled trials have reported effective postoperative analgesia, with non-intramuscular QLB for cesarean sections, laparoscopic gynecologic surgery and hip hemiarthroplasty .
The intramuscular QLB (QLBi) technique was first reported by. This approach is different from others in tubouchi for QLB; although the injection target sites of the other approaches are planes around the quadratus lumborum muscle, the intramuscular approach penetrates the fascia of the quadratus lumborum muscle, where local anesthetics are injected. Therefore, QLBi is relatively easier to perform compared with other QLB approaches.
The incidence of urinary bladder cancer in the Middle East and Africa is greater in areas with high rather than low SH prevalence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (QLBA) will include 30 patients | Experimental | Procedure: US guided injectionwill receive ultrasound-guided anterior approach quadratus lumborum block |
| Group 2 (QLBI)will include 30 patients. | Experimental | Procedure: US guided injectionreceived ultrasound-guided intramuscular quadratus lumborum. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 40-70years.
Key exclusion criteria (7 listed)
- • Patient's refusal to participate in the study.
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 |
|---|---|---|
| US guided injectionusing 2.5mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , received ultrasound-guided quadratus lumborum. | Procedure or surgery | Group 1 (QLBA) will include 30 patients, Group 2 (QLBI)will include 30 patients. |
Primary outcome
Evaluate the first call for rescue analgesia
Time frame: 24hours after recovery From anesthesia
The time of the first call of analgesia is recorded
1 secondary outcome
Total doses of morphine required
Time frame: 24hours after recovery from anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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.
Abdel raheem Mahmoud Mohamed, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US guided injection in people with Quadratus Lumborum Block, run by Assiut 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 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 31 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Mostafa abdelbaky ahmed, Master (01060264751, hassan.mostafa9444@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the first call for rescue analgesia (time frame: 24hours after recovery From anesthesia). 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 31 Jul 2024.