AnalgesiaNCT04827121
Comparison of Fascial Iliac Compartment Block and Quadratus Lumborum Block for Hip Surgery
A study testing Fascial iliac compartment block and Quadratus lumborum block in people with Analgesia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Iliac fascia block has a long history of analgesia in patients with hip fractures. A large number of clinical studies have confirmed its efficacy, and there are also randomized controlled studies supporting its effectiveness in analgesia after total hip replacement surgery.Quadratus lumborum block is a new block… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Fascial iliac compartment block and Quadratus lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2021to 1 Jun 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class 1-3
- BMI between 20-36kg/m^2
- Scheduled to undergo total hip replacement
Who cannot join
- A history of chronic opioids or steroid consumption
- Coagulapathy or anticoagulation
- Pregnancy
- Allergic to local anesthetics Neurological dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shuguang Yang, M.D, +86-150-7107-8161, yangsuperpro@163.com
Wei Mei, MD.
About this study
Official title: Transmuscular Quadratus Lumborum Block Versus Supra-inguinal Fascial Iliac Compartment Block for Total Hip Arthroplasty: a Randomized, Prospective Study
Iliac fascia block has a long history of analgesia in patients with hip fractures. A large number of clinical studies have confirmed its efficacy, and there are also randomized controlled studies supporting its effectiveness in analgesia after total hip replacement surgery.Quadratus lumborum block is a new block technique developed in last decade, and there are also a few randomized controlled studies supporting its effectiveness in postoperative analgesia for total hip replacement.The purpose of the present study was to find out whether these two different approaches of fascial compartment block have similar effects on postoperative analgesia after total hip replacement.
- Conditions
- Analgesia
- Being tested
- Fascial iliac compartment block, Quadratus lumborum block
- Keywords
- Ultrasound, Total hip arthroplasty, Nerve block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial iliac compartment blockProcedure or surgery
Patients will recieve supra-inguinal approach of fascial iliac compartment block under ultrasound guidance with 30 ml of 0.5 percent ropivacaine.
Quadratus lumborum blockProcedure or surgery
Patients will recieve transmuscular approach of quadratus lumborum block under ultrasound guidance with 30 ml of 0.5 percent ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Fascial iliac compartment block group | Active comparator | Patients in this group will recieve supra-inguinal fascial iliac compartment block after anesthesia induction. Receives: Procedure: Fascial iliac compartment block |
| Quadratus lumborum block group | Active comparator | Patients in this group will recieve quadratus lumborum block after anesthesia induction. Receives: Procedure: Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioids consumption at 24 hours
Cumulative consumption of sufentanil from PCA device at 24 hours after surgery
Measured: Within 24 hours
Secondary outcomes (1)
NRS score with movement at 6,12,and 24 hours
Patients' NRS score with movement at 6,12,and 24 hours after surgery
Measured: at 6,12,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 posted1 Apr 2021
- Study start31 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827121
- Sponsor's protocol ID
- TJ-IRB20210141
- Status last verified
- Jun 2021
- First submitted
- 30 Mar 2021
- Last updated
- 8 Jun 2021
- 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 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmuscular Quadratus Lumborum Block Versus Supra-inguinal Fascial Iliac Compartment Block for Total Hip Arthroplasty: a Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT04827121
- Acronym / sponsor ID
- TJ-IRB20210141
- Conditions
- Analgesia
- Keywords
- Ultrasound, Total hip arthroplasty, Nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 1 Apr 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.
Iliac fascia block has a long history of analgesia in patients with hip fractures. A large number of clinical studies have confirmed its efficacy, and there are also randomized controlled studies supporting its effectiveness in analgesia after total hip replacement surgery.Quadratus lumborum block is a new block technique developed in last decade, and there are also a few randomized controlled studies supporting its effectiveness in postoperative analgesia for total hip replacement.The purpose of the present study was to find out whether these two different approaches of fascial compartment block have similar effects on postoperative analgesia after total hip replacement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascial iliac compartment block group | Active comparator | Procedure: Fascial iliac compartment blockPatients in this group will recieve supra-inguinal fascial iliac compartment block after anesthesia induction. |
| Quadratus lumborum block group | Active comparator | Procedure: Quadratus lumborum blockPatients in this group will recieve quadratus lumborum block after anesthesia induction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class 1-3
- BMI between 20-36kg/m^2
- Scheduled to undergo total hip replacement
Key exclusion criteria (4 listed)
- A history of chronic opioids or steroid consumption
- Coagulapathy or anticoagulation
- Pregnancy
- Allergic to local anesthetics Neurological dysfunction
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 |
|---|---|---|
| Fascial iliac compartment blockPatients will recieve supra-inguinal approach of fascial iliac compartment block under ultrasound guidance with 30 ml of 0.5 percent ropivacaine. | Procedure or surgery | Fascial iliac compartment block group |
| Quadratus lumborum blockPatients will recieve transmuscular approach of quadratus lumborum block under ultrasound guidance with 30 ml of 0.5 percent ropivacaine. | Procedure or surgery | Quadratus lumborum block group |
Primary outcome
Cumulative opioids consumption at 24 hours
Time frame: Within 24 hours
Cumulative consumption of sufentanil from PCA device at 24 hours after surgery
1 secondary outcome
NRS score with movement at 6,12,and 24 hours
Time frame: at 6,12,and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- 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.
Wei Mei, PhD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial iliac compartment block and Quadratus lumborum block in people with Analgesia, run by Huazhong University of Science and Technology at 1 site in China.
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 4 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 8 Jun 2021. 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 China. 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 Shuguang Yang, M.D. (+86-150-7107-8161, yangsuperpro@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioids consumption at 24 hours (time frame: Within 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 8 Jun 2021.