Hip SurgeriesPhase 4NCT04628689
Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach With Different Concentrations Of Bupivacaine in Hip Surgeries
A Phase 4 study testing quadratus lumborum block by paraspinous sagittal shift approach in people with Hip Surgeries, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the optimum concentration of bupivacaine in Paraspinous Sagittal Shift Approach for Quadratus Lumborum Block in hip Surgeries Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Surgeries
- What is being tested?
- quadratus lumborum block by paraspinous sagittal shift approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2020to 30 Dec 2020
- Phase
- Phase 4
- 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 undergoing hip surgery.
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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benisuef univercity
Banī Suwayf, Benisuef, 62511
Doaa Rashwan, MD, 01011270763, doaa_rashwan@hotmail.com
Samaa Rashwan, MD Rashwan, MD
About this study
Official title: Comparison Of The Analgesic Efficacy Of Quadratus Lumborum Block By Paraspinous Sagittal Shift Approach With Different Concentrations Of Bupivacaine in Hip Surgeries
The aim of this study is to evaluate the optimum concentration of bupivacaine in Paraspinous Sagittal Shift Approach for Quadratus Lumborum Block in hip Surgeries
Read the detailed description
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. After subcutaneous local infiltration with lidocaine at the cephalic end of the probe, the block needle is advanced in a cephalo-caudal direction, through the erector spinae and QL muscles, until it pierces the epimysium of the QL. LA is injected anterior to the QL muscle, observing its spread in a caudal direction towards the iliac crest between the QL and psoas muscles
- Conditions
- Hip Surgeries
- Being tested
- quadratus lumborum block by paraspinous sagittal shift approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadratus lumborum block by paraspinous sagittal shift approachOther
quadratus lumborum block by paraspinous sagittal shift approach
| Study group | Role | What they receive |
|---|---|---|
| Group 0.25% bupivacaine | Active comparator | 30 ml 0.25% bupivacaine Receives: Other: quadratus lumborum block by paraspinous sagittal shift approach |
| Group 0.375% bupivacaine | Active comparator | 0.375% bupivacaine Receives: Other: quadratus lumborum block by paraspinous sagittal shift approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first request of analgesics
Postoperative time to first request of analgesics (hours)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 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 Hip SurgeriesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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
- NCT04628689
- Sponsor's protocol ID
- FMBSUREC/01092020/Abd El Badei
- Status last verified
- Nov 2020
- First submitted
- 30 Sep 2020
- Last updated
- 20 Nov 2020
- Results posted
- 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 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Analgesic Efficacy Of Quadratus Lumborum Block By Paraspinous Sagittal Shift Approach With Different Concentrations Of Bupivacaine in Hip Surgeries
- ClinicalTrials.gov ID
- NCT04628689
- Acronym / sponsor ID
- FMBSUREC/01092020/Abd El Badei
- Conditions
- Hip Surgeries
- Phase
- Phase 4
- 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
- 13 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 aim of this study is to evaluate the optimum concentration of bupivacaine in Paraspinous Sagittal Shift Approach for Quadratus Lumborum Block in hip Surgeries
Detailed description
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. After subcutaneous local infiltration with lidocaine at the cephalic end of the probe, the block needle is advanced in a cephalo-caudal direction, through the erector spinae and QL muscles, until it pierces the epimysium of the QL. LA is injected anterior to the QL muscle, observing its spread in a caudal direction towards the iliac crest between the QL and psoas muscles
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 0.25% bupivacaine | Active comparator | Other: quadratus lumborum block by paraspinous sagittal shift approach30 ml 0.25% bupivacaine |
| Group 0.375% bupivacaine | Active comparator | Other: quadratus lumborum block by paraspinous sagittal shift approach0.375% bupivacaine |
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 undergoing hip surgery.
Key exclusion criteria (1 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
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 block by paraspinous sagittal shift approachquadratus lumborum block by paraspinous sagittal shift approach | Other | Group 0.25% bupivacaine, Group 0.375% bupivacaine |
Primary outcome
time to first request of analgesics
Time frame: Postoperative 24 hours
Postoperative time to first request of analgesics (hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing quadratus lumborum block by paraspinous sagittal shift approach in people with Hip Surgeries, run by Beni-Suef 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 1 inclusion and 1 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 20 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact doaa rashwan (00201011270763, doaa_rashwan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first request of analgesics (time frame: Postoperative 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 20 Nov 2020.