Postoperative PainNCT04709211
Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block
A study testing Facia Iliaca block, Anterior Quadratus Lumbroum block and bupivacaine in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Fractures of the femur are common orthopaedic emergency especially in the geriatric population and central neuraxial blocks are the preferred technique for providing anaesthesia. However, limb immobility and extreme pain are the deterrents for ideal positioning for these procedures. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Facia Iliaca block, Anterior Quadratus Lumbroum block and bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2021to 1 Jul 2021
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA II to IV
- Both sexes
- scheduled for fracture femur surgeries
Who cannot join
- patients with bleeding disorders and coagulopathy
- infection at the injection site
- known allergy to local anaesthetics
- patients with multiple fractures
- patients with pre-existing myopathy or neuropathy
- patients with significant cognitive dysfunction
- patients who receive long-acting opioids preoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Postoperative Analgesia of Fascia Iliaca Compartment Block and Anterior Quadratus Lumborum Block in Proximal Femur Fracture
Fractures of the femur are common orthopaedic emergency especially in the geriatric population and central neuraxial blocks are the preferred technique for providing anaesthesia. However, limb immobility and extreme pain are the deterrents for ideal positioning for these procedures. postoperative pain is a nightmare so adequate analgesia has been advocated to reduce the pain. in this study, Facia Iliaca compartment block will be compared to anterior Quadratus lumborum block, both will be done Ultrasound-guided using Bupivacain0.25% for postoperative analgesia at the end of the surgery.
Read the detailed description
In this prospective, randomized, comparative study patients will be equally divided into two equal groups; GroupI: patients will receive Ultrasound-guided Facia Iliaca compartment block with 50 ml 0.25%bupivacaine at the end of surgery Group Q: patients will receive Ultrasound-guided anterior Quadratus lumborum block with 50 ml 0.25%bupivacaine at the end of surgery
- Conditions
- Postoperative Pain
- Being tested
- Facia Iliaca block, Anterior Quadratus Lumbroum block, bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facia Iliaca blockProcedure or surgery
patients will receive Ultrasound-guided Facia Iliaca block using 50 ml 0f Bupivacaine 0.25%
Anterior Quadratus Lumbroum blockProcedure or surgery
patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using 50 ml 0f Bupivacaine 0.25%
bupivacaineDrug
bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group I: Facia Iliaca block | Active comparator | patients will receive Ultrasound-guided Facia Iliaca Block using bupivacaine 0.25% Receives: Procedure: Facia Iliaca block |
| Group Q: Anterior Quadratus lumbroum block | Active comparator | patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using bupivacaine 0.25% Receives: Procedure: Anterior Quadratus Lumbroum block; Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
first request of analgesia
the time the patient felt pain and asked for analgesics
Measured: 48 hours postoperative
Secondary outcomes (1)
total opioid consumption
total dose of fentanyl used
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start10 Jan 2021
- Primary completion30 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
- Investigators
- Fathy M Tash, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709211
- Sponsor's protocol ID
- FMASU M D 260/2020
- Status last verified
- Oct 2024
- First submitted
- 7 Jan 2021
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Postoperative Analgesia of Fascia Iliaca Compartment Block and Anterior Quadratus Lumborum Block in Proximal Femur Fracture
- ClinicalTrials.gov ID
- NCT04709211
- Acronym / sponsor ID
- FMASU M D 260/2020
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 14 Jan 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.
Fractures of the femur are common orthopaedic emergency especially in the geriatric population and central neuraxial blocks are the preferred technique for providing anaesthesia. However, limb immobility and extreme pain are the deterrents for ideal positioning for these procedures. postoperative pain is a nightmare so adequate analgesia has been advocated to reduce the pain. in this study, Facia Iliaca compartment block will be compared to anterior Quadratus lumborum block, both will be done Ultrasound-guided using Bupivacain0.25% for postoperative analgesia at the end of the surgery.
Detailed description
In this prospective, randomized, comparative study patients will be equally divided into two equal groups; GroupI: patients will receive Ultrasound-guided Facia Iliaca compartment block with 50 ml 0.25%bupivacaine at the end of surgery Group Q: patients will receive Ultrasound-guided anterior Quadratus lumborum block with 50 ml 0.25%bupivacaine at the end of surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Facia Iliaca block | Active comparator | Procedure: Facia Iliaca blockpatients will receive Ultrasound-guided Facia Iliaca Block using bupivacaine 0.25% |
| Group Q: Anterior Quadratus lumbroum block | Active comparator | Procedure: Anterior Quadratus Lumbroum block, Drug: bupivacainepatients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using bupivacaine 0.25% |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA II to IV
- Both sexes
- scheduled for fracture femur surgeries
Key exclusion criteria (7 listed)
- patients with bleeding disorders and coagulopathy
- infection at the injection site
- known allergy to local anaesthetics
- patients with multiple fractures
- patients with pre-existing myopathy or neuropathy
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 |
|---|---|---|
| Facia Iliaca blockpatients will receive Ultrasound-guided Facia Iliaca block using 50 ml 0f Bupivacaine 0.25% | Procedure or surgery | Group I: Facia Iliaca block |
| Anterior Quadratus Lumbroum blockpatients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using 50 ml 0f Bupivacaine 0.25% | Procedure or surgery | Group Q: Anterior Quadratus lumbroum block |
| bupivacainebupivacaine | Drug | Group Q: Anterior Quadratus lumbroum block |
Primary outcome
first request of analgesia
Time frame: 48 hours postoperative
the time the patient felt pain and asked for analgesics
1 secondary outcome
total opioid consumption
Time frame: 48 hours postoperative
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 9 Oct 2024.
- 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.
Fathy M Tash, MD study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facia Iliaca block, Anterior Quadratus Lumbroum block and bupivacaine in people with Postoperative Pain, run by Ain Shams 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 3 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: finished, as of the sponsor's last update on 9 Oct 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?
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?
first request of analgesia (time frame: 48 hours postoperative). 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 9 Oct 2024.