Regional AnesthesiaNCT04670497
Perioperative Analgesia for Total Hip Arthroplasty
A study testing bupivacaine 0.5% with 1:200000 adrenaline in people with Regional Anesthesia, run by Menoufia University at 1 site in Egypt.
Trial summary
This study is comparing the effect of lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- bupivacaine 0.5% with 1:200000 adrenaline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 May 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA physical status I-II and scheduled for elective total hip arthroplasty
Who cannot join
- Patients who refuse to participate.
- Local infection.
- Patients with coagulation defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Analgesia for Total Hip Arthroplasty: Lumbar Plexus Block Using Shamrock Technique Versus Fascia Iliaca Block
This study is comparing the effect of lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics
Read the detailed description
Different groups receive different interventions at same time during study. patients were randomly allocated in two groups :
Group A: lumbar plexus block using shamrock technique by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.
Group B: Fascia iliaca block by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.
- Conditions
- Regional Anesthesia
- Being tested
- bupivacaine 0.5% with 1:200000 adrenaline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine 0.5% with 1:200000 adrenalineProcedure or surgery
regional anesthesia to block lumbar plexus for analgesia of lower limb
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided lumbar plexus block | Active comparator | patients were recieved lumbar plexus block ultrasound guided by shamrock technique using 0.5% bupavacaine in a dose 0.3ml/kg Receives: Procedure: bupivacaine 0.5% with 1:200000 adrenaline |
| ultrasound guided Fascia iliaca block | Active comparator | patients were received fascia iliaca block ultrasound guided using 0.5% bupoavacaine in a dose 0.3ml\kg Receives: Procedure: bupivacaine 0.5% with 1:200000 adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative analgesia
each patient was assessed by visual analogue scale which consists of a 10 cm line with one end labelled "no pain" and the other end labelled "worst pain imaginable". The patient marks the line at the point that best describes the pain intensity
Measured: 24 hours
Secondary outcomes (1)
Compare effects of both groups on mean arterial blood pressure
monitoring of blood pressure using non invasive blood pressure measurement in millimeter mercury
Measured: intraoperative and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jul 2018
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Model description
- This study is comparing the effect of Lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed hashem, Menoufia University
- Investigators
- ahmed abd elraof, professor, Study chair, faculty of medicine, anesthesia departmentEzz elden saleh, professor, Study chair, faculty of medicine, anesthesia departmentsadek abdelmasih, lecturer, Study director, faculty of medicine, anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670497
- Sponsor's protocol ID
- ANET 8/2018
- Status last verified
- Jul 2018
- First submitted
- 25 Nov 2020
- Last updated
- 17 Dec 2020
- 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesia for Total Hip Arthroplasty: Lumbar Plexus Block Using Shamrock Technique Versus Fascia Iliaca Block
- ClinicalTrials.gov ID
- NCT04670497
- Acronym / sponsor ID
- ANET 8/2018
- Conditions
- Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 17 Dec 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.
This study is comparing the effect of lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics
Detailed description
Different groups receive different interventions at same time during study. patients were randomly allocated in two groups :
Group A: lumbar plexus block using shamrock technique by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.
Group B: Fascia iliaca block by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is comparing the effect of Lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics.
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided lumbar plexus block | Active comparator | Procedure: bupivacaine 0.5% with 1:200000 adrenalinepatients were recieved lumbar plexus block ultrasound guided by shamrock technique using 0.5% bupavacaine in a dose 0.3ml/kg |
| ultrasound guided Fascia iliaca block | Active comparator | Procedure: bupivacaine 0.5% with 1:200000 adrenalinepatients were received fascia iliaca block ultrasound guided using 0.5% bupoavacaine in a dose 0.3ml\kg |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-II and scheduled for elective total hip arthroplasty
Key exclusion criteria (3 listed)
- Patients who refuse to participate.
- Local infection.
- Patients with coagulation defects
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 |
|---|---|---|
| bupivacaine 0.5% with 1:200000 adrenalineregional anesthesia to block lumbar plexus for analgesia of lower limb | Procedure or surgery | ultrasound guided Fascia iliaca block, ultrasound guided lumbar plexus block |
Primary outcome
Assessment of postoperative analgesia
Time frame: 24 hours
each patient was assessed by visual analogue scale which consists of a 10 cm line with one end labelled "no pain" and the other end labelled "worst pain imaginable". The patient marks the line at the point that best describes the pain intensity
1 secondary outcome
Compare effects of both groups on mean arterial blood pressure
Time frame: intraoperative and 24 hours
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 17 Dec 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.
ahmed abd elraof, professor study chair
faculty of medicine, anesthesia department
Ezz elden saleh, professor study chair
faculty of medicine, anesthesia department
sadek abdelmasih, lecturer study director
faculty of medicine, anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine 0.5% with 1:200000 adrenaline in people with Regional Anesthesia, run by Menoufia 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 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: finished, as of the sponsor's last update on 17 Dec 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?
Assessment of postoperative analgesia (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 17 Dec 2020.