Self EfficacyPhase 3NCT04628923
Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach for Hip Surgery
A Phase 3 study testing QUADRATUS LUMBORUM BLOCK in people with Self Efficacy, run by Beni-Suef University.
Trial summary
The quadratus lumborum block (QLB) was first described by Blanco. it is a compartment block procedure during which a local anesthetic is injected into the muscle plane of the quadratus lumborum (QL) muscle under ultrasound guidance Currently, QLB is divided into four types based on the injection point of the local… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy
- What is being tested?
- QUADRATUS LUMBORUM BLOCK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2020to 30 Dec 2020
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- -ASA I and II
Who cannot join
- Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy)
- Allergic reaction to drugs.
- opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs
About this study
Official title: Tthe Anaesthetic Efficacy of Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach for Hip Surgery:a Case Series
The quadratus lumborum block (QLB) was first described by Blanco. it is a compartment block procedure during which a local anesthetic is injected into the muscle plane of the quadratus lumborum (QL) muscle under ultrasound guidance Currently, QLB is divided into four types based on the injection point of the local anesthetic: lateral, anterior, posterior, and intramuscular QLB. QLB is widely used for various types of abdominal surgeries (
Read the detailed description
the investigators will evaluate the anesthetic efficacy of quadratus lumborum block by paraspinous sagittal shift approach for hip surgery by injecting 30 ml of 0. 5% bupivacaine.
- Conditions
- Self Efficacy
- Being tested
- QUADRATUS LUMBORUM BLOCK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUADRATUS LUMBORUM BLOCKOther
QUADRATUS LUMBORUM BLOCK BY PARASPINOUS SAGITTAL SHIFT APPROACH
| Study group | Role | What they receive |
|---|---|---|
| QLB | Experimental | With the patient in the lateral decubitus and the block side independent, a curvilinear ultrasound transducer (2-5 MHz) will be directed caudally in a sagittal plane 3-4 cm lateral to the lumbar spinous process of L4, which is almost opposite to the iliac crest, producing a longitudinal scan of the lumbar paravertebral region; and thus identifying the transverse processes of L3 and L4, with PM muscle in-between and erector spinae muscle posteriorly.
The probe is shifted slowly to the lateral side until the transverse processes disappear and the QL muscle is evident in its long axis attached caudally to the iliac crest with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, QL, and PM muscles respectively. Receives: Other: QUADRATUS LUMBORUM BLOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory and motor block level
BY PIN PRICK
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start20 Nov 2020 (estimated)
- Primary completion30 Dec 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 Self EfficacyStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doaa rashwan, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628923
- Sponsor's protocol ID
- FMBSUREC/05072020/AbdEl Badei2
- Status last verified
- Nov 2020
- First submitted
- 18 Sep 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tthe Anaesthetic Efficacy of Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach for Hip Surgery:a Case Series
- ClinicalTrials.gov ID
- NCT04628923
- Acronym / sponsor ID
- FMBSUREC/05072020/AbdEl Badei2
- Conditions
- Self Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 16 Nov 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.
The quadratus lumborum block (QLB) was first described by Blanco. it is a compartment block procedure during which a local anesthetic is injected into the muscle plane of the quadratus lumborum (QL) muscle under ultrasound guidance Currently, QLB is divided into four types based on the injection point of the local anesthetic: lateral, anterior, posterior, and intramuscular QLB. QLB is widely used for various types of abdominal surgeries (
Detailed description
the investigators will evaluate the anesthetic efficacy of quadratus lumborum block by paraspinous sagittal shift approach for hip surgery by injecting 30 ml of 0. 5% bupivacaine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLB | Experimental | Other: QUADRATUS LUMBORUM BLOCKWith the patient in the lateral decubitus and the block side independent, a curvilinear ultrasound transducer (2-5 MHz) will be directed caudally in a sagittal plane 3-4 cm lateral to the lumbar spinous process of L4, which is almost opposite to the iliac crest, producing a longitudinal scan of the lumbar paravertebral region; and thus identifying the transverse processes of L3 and L4, with PM muscle in-between and erector spinae muscle posteriorly. The probe is shifted slowly to the lateral side until the transverse processes disappear and the QL muscle is evident in its long axis attached caudally to the iliac crest with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, QL, and PM muscles respectively. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -ASA I and II
Key exclusion criteria (3 listed)
- Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy)
- Allergic reaction to drugs.
- opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs
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 LUMBORUM BLOCKQUADRATUS LUMBORUM BLOCK BY PARASPINOUS SAGITTAL SHIFT APPROACH | Other | QLB |
Primary outcome
sensory and motor block level
Time frame: immediately after the intervention/procedure/surgery
BY PIN PRICK
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Self Efficacy
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QUADRATUS LUMBORUM BLOCK in people with Self Efficacy, run by Beni-Suef University.
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 1 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 16 Nov 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
sensory and motor block level (time frame: immediately after the intervention/procedure/surgery). 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 Nov 2020.