Pain, PostoperativeNCT03502369
Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty
A study testing Anterior Quadratus lamborum block in people with Pain, Postoperative, run by Alexandria University at 1 site in Egypt.
Trial summary
The study evaluates the effectiveness of anterior quadratus lumborum block for post operative analgesia after hip arthroplasty. Half of the participants will receive ultrasound guided anterior quadratus lumborum block using 30ml bupivacaine 0.375%, while the other half will not receive the block ( control group). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Anterior Quadratus lamborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2018to Mar 2019
- 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
- American society of anesthesiologists physical status |-||| , scheduled to undergo unilateral hip replacement via lateral approach.
Who cannot join
- patient refusal.
- History of neurological/neuromuscular, psychiatric, dementia preventing proper comprehension.
- coagulation disorders.
- History of allergy to the study medication.
- Infection overlying the injection site.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria faculty of medicine
Alexandria, 21519
moutaz Ghandour, professor, 01003363712, moutaz.ghandour@alexmed.edu.eg
Abdullah Gaber, MD
About this study
Official title: Randomized, Controlled, Double Blind Trial of Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty
The study evaluates the effectiveness of anterior quadratus lumborum block for post operative analgesia after hip arthroplasty. Half of the participants will receive ultrasound guided anterior quadratus lumborum block using 30ml bupivacaine 0.375%, while the other half will not receive the block ( control group).
Read the detailed description
Sensory innervation of the hip region involves branches of the lumbar plexus and sacral plexus. Effective post operative analgesia can be approached by blocking the lumbar plexus at the level of the quadratus lumborum muscle. Quadratus lumborum block has several approach methods (anterior, lateral, posterior, and intramuscular). Anterior quadratus lumborum block also known as transmuscular QL block or QL3, the local anaesthetic (30ml of bupivacaine 0.375%) is injected between the psoas major muscle (PM) and the quadratus lumborum muscle (QL). Therefore, the anterior quadratus lumborum block may generate analgesia from T10 to L4 covering the sensory innervation of the hip region.
- Conditions
- Pain, Postoperative
- Being tested
- Anterior Quadratus lamborum block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Quadratus lamborum blockProcedure or surgery
Also called Transmuscular QL block, QL3
Local anaesthetic will be injected in the fascial plane between psoas major muscle and quadratus lumborum muscle.
| Study group | Role | What they receive |
|---|---|---|
| QL group | Experimental | Anterior Quadratus lumborum block will be done for all patients of these group. Local anaesthetic (30ml of bupivacaine) will be injected in fascial plane between the quadratus lumborum muscle and Psoas major muscle by using the ultrasound. Receives: Procedure: Anterior Quadratus lamborum block |
| C group | No intervention | Patients of these group will be the control group. The will receive acetaminophen 1g every 8h, ketorolac 30mg ever 12h and as required morphine 2mg for post operative analgesia after hip arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessment
Patients will be trained to use visual analogue scale which consists of 10cm line, 0 cm equivalent to no pain and 10 cm denoting the worst imaginable pain.
Measured: every hour for the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.
Secondary outcomes (1)
Total amount of post operative morphine (mg).
Total amount of post operative morphine (mg) used as rescue analgesia and the first time of its request.
Measured: any time in the first 24 post operative hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study startSep 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Adult 90 orthopaedic patient ASA physical status \|-\|\|\| will be randomly allocated in two groups each one 45 patients, one group will receive the anterior quadratus lumborum block and the other group will not receive the block.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Gaber, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502369
- Sponsor's protocol ID
- 050108004
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
PubMed 26426575
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double Blind Trial of Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03502369
- Acronym / sponsor ID
- 050108004
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 18 Apr 2018 (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 study evaluates the effectiveness of anterior quadratus lumborum block for post operative analgesia after hip arthroplasty. Half of the participants will receive ultrasound guided anterior quadratus lumborum block using 30ml bupivacaine 0.375%, while the other half will not receive the block ( control group).
Detailed description
Sensory innervation of the hip region involves branches of the lumbar plexus and sacral plexus. Effective post operative analgesia can be approached by blocking the lumbar plexus at the level of the quadratus lumborum muscle. Quadratus lumborum block has several approach methods (anterior, lateral, posterior, and intramuscular). Anterior quadratus lumborum block also known as transmuscular QL block or QL3, the local anaesthetic (30ml of bupivacaine 0.375%) is injected between the psoas major muscle (PM) and the quadratus lumborum muscle (QL). Therefore, the anterior quadratus lumborum block may generate analgesia from T10 to L4 covering the sensory innervation of the hip region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Adult 90 orthopaedic patient ASA physical status |-||| will be randomly allocated in two groups each one 45 patients, one group will receive the anterior quadratus lumborum block and the other group will not receive the block.
| Arm | Type | Receives |
|---|---|---|
| QL group | Experimental | Procedure: Anterior Quadratus lamborum blockAnterior Quadratus lumborum block will be done for all patients of these group. Local anaesthetic (30ml of bupivacaine) will be injected in fascial plane between the quadratus lumborum muscle and Psoas major muscle by using the ultrasound. |
| C group | No intervention | –Patients of these group will be the control group. The will receive acetaminophen 1g every 8h, ketorolac 30mg ever 12h and as required morphine 2mg for post operative analgesia after hip arthroplasty. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American society of anesthesiologists physical status |-||| , scheduled to undergo unilateral hip replacement via lateral approach.
Key exclusion criteria (5 listed)
- patient refusal.
- History of neurological/neuromuscular, psychiatric, dementia preventing proper comprehension.
- coagulation disorders.
- History of allergy to the study medication.
- Infection overlying the injection site.
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 |
|---|---|---|
| Anterior Quadratus lamborum blockAlso: Transmuscular QL block, QL3Local anaesthetic will be injected in the fascial plane between psoas major muscle and quadratus lumborum muscle. | Procedure or surgery | QL group |
Primary outcome
Pain intensity assessment
Time frame: every hour for the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.
Patients will be trained to use visual analogue scale which consists of 10cm line, 0 cm equivalent to no pain and 10 cm denoting the worst imaginable pain.
1 secondary outcome
Total amount of post operative morphine (mg).
Time frame: any time in the first 24 post operative hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Background: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Results publication: PubMed 26426575Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
- Individual participant dataSharing planned: Yes. De identified individual participant data for all primary and secondary outcome measures will be made available.
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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 study testing Anterior Quadratus lamborum block in people with Pain, Postoperative, run by Alexandria 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 5 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 19 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessment (time frame: every hour for the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502369, which also lists 2 linked publications.
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 19 Apr 2018.