Quadratus Lumborum BlockNCT05465967
Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty
A study testing Quadratus lumborum Block in people with Quadratus Lumborum Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between the post-operative analgesic effect of two approaches of transmuscular quadratus lumborum block (transverse versus paraspinous sagittal transmuscular QLB) in total hip replacement surgery. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadratus Lumborum Block
- What is being tested?
- Quadratus lumborum Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Sep 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 75 patients, aged between 21- 80 years old, of both sex American society of Anesthesiology I - III scheduled for total hip replacement surgery.
Who cannot join
- Patient refusal.
- Coagulopathy
- Spinal deformities
- Peripheral neuropathy; sensory disorders in the leg requiring surgery and chronic pain.
- Mental dysfunction, psychiatric illnesses and cognitive dysfunction.
- History of drug abuse \&chronic analgesic use
Trial locations and contacts
1 site in 1 country.
Mohammed Sh Elbrol, MD contact
About this study
Official title: A Comparative Study Between Two Approaches of Ultrasound-Guided Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty
The aim of this study is to compare between the post-operative analgesic effect of two approaches of transmuscular quadratus lumborum block (transverse versus paraspinous sagittal transmuscular QLB) in total hip replacement surgery.
Read the detailed description
During the preanesthetic assessment, all patients will be educated about the visual analogue scale (VAS) for pain assessment, with scores ranging from 0 to 10 (0 represent no pain, while10 represent maximum intolerable pain).
The patients will be randomly classified into three equal groups (25 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and postoperative assessor will be blinded to group assignment.
Patients will be randomized to one of three equal groups:
- Group I: Control group (n= 25 patients): Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.
- Group II (n= 25 patients): Patients in this group will receive an ipsilateral single shot of transverse transmuscular approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
- Group III (n= 25 patients): patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
- Conditions
- Quadratus Lumborum Block
- Being tested
- Quadratus lumborum Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum BlockProcedure or surgery
1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Control Group | Sham comparator | Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery. Receives: Procedure: Quadratus lumborum Block |
| Group II:( transverse trans muscular Quadratus lumborum group). | Active comparator | patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK(30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance. Receives: Procedure: Quadratus lumborum Block |
| Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK | Active comparator | patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance. Receives: Procedure: Quadratus lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
Total Morphine consumption in the first 24 h of the post-operative period .
Measured: Baseline
Secondary outcomes (1)
Postoperative pain score
- Postoperative pain will be assessed by VAS (score for the severity of pain in the range 0-10, where 0 = no pain and 10 = severe pain) at 2,4,6,12,18,24 hours. If the VAS is 4 or more, 3 mg of intravenous morphine will be given as a rescue analgesia.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Sep 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (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 Quadratus Lumborum BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Abdelhaleem Kamal Nida, Tanta University
- Investigators
- YASSER M RAGHEB, PROF, Study chair, TANYAU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465967
- Sponsor's protocol ID
- QL block on hip arthroplasty
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.
PubMed 20462458Abduallah MA, Ahmed SA, Abdelghany MS. The effect of post-operative ultrasound-guided transmuscular quadratus lumborum block on post-operative analgesia after hip arthroplasty in elderly patients: A randomised controlled double-blind study. Indian J Anaesth. 2020 Oct;64(10):887-893. doi: 10.4103/ija.IJA_275_20. Epub 2020 Oct 1.
PubMed 33437078
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Two Approaches of Ultrasound-Guided Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05465967
- Acronym / sponsor ID
- QL block on hip arthroplasty
- Conditions
- Quadratus Lumborum Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 20 Jul 2022 (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 compare between the post-operative analgesic effect of two approaches of transmuscular quadratus lumborum block (transverse versus paraspinous sagittal transmuscular QLB) in total hip replacement surgery.
Detailed description
During the preanesthetic assessment, all patients will be educated about the visual analogue scale (VAS) for pain assessment, with scores ranging from 0 to 10 (0 represent no pain, while10 represent maximum intolerable pain).
The patients will be randomly classified into three equal groups (25 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and postoperative assessor will be blinded to group assignment.
Patients will be randomized to one of three equal groups:
- Group I: Control group (n= 25 patients): Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.
- Group II (n= 25 patients): Patients in this group will receive an ipsilateral single shot of transverse transmuscular approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
- Group III (n= 25 patients): patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: Control Group | Sham comparator | Procedure: Quadratus lumborum BlockPatients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery. |
| Group II:( transverse trans muscular Quadratus lumborum group). | Active comparator | Procedure: Quadratus lumborum Blockpatients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK(30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance. |
| Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK | Active comparator | Procedure: Quadratus lumborum Blockpatients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 75 patients, aged between 21- 80 years old, of both sex American society of Anesthesiology I - III scheduled for total hip replacement surgery.
Key exclusion criteria (6 listed)
- Patient refusal.
- Coagulopathy
- Spinal deformities
- Peripheral neuropathy; sensory disorders in the leg requiring surgery and chronic pain.
- Mental dysfunction, psychiatric illnesses and cognitive 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 |
|---|---|---|
| Quadratus lumborum Block1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected. | Procedure or surgery | Group I: Control Group, Group II:( transverse trans muscular Quadratus lumborum group)., Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK |
Primary outcome
Postoperative morphine consumption
Time frame: Baseline
Total Morphine consumption in the first 24 h of the post-operative period .
1 secondary outcome
Postoperative pain score
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 20462458Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.
- Background: PubMed 33437078Abduallah MA, Ahmed SA, Abdelghany MS. The effect of post-operative ultrasound-guided transmuscular quadratus lumborum block on post-operative analgesia after hip arthroplasty in elderly patients: A randomised controlled double-blind study. Indian J Anaesth. 2020 Oct;64(10):887-893. doi: 10.4103/ija.IJA_275_20. Epub 2020 Oct 1.
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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.
Mohammed Sh Elbrol, MD contact
YASSER M RAGHEB, PROF study chair
TANYAU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus lumborum Block in people with Quadratus Lumborum Block, run by Tanta 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 6 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 26 Jul 2022. 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. Some participants in this study may receive a placebo. 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 mai A nida, msc (+201012328193, mai.nida90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine consumption (time frame: Baseline). 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 NCT05465967, 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 26 Jul 2022.