Total Hip ArthroplastyNCT03945630
Quadratus Lumborum Block in Total Hip Arthroplasty - Effect on Analgesia and Early Physiotherapy
A study testing anterior Quadratus Lumborum Block in people with Total Hip Arthroplasty, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Currently there is no consensus on the optimal peripheral nerve block for Total Hip Arthroplasty (THA). Furthermore, there is a gap in the literature in regard to the efficacy of Quadratus Lumborum Block (QLB) for Total Hip Arthroplasty via posterior approach. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- anterior Quadratus Lumborum Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 14 May 2019to Apr 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral total hip arthroplasty
- Adults 18 - 90 years.
- ASA classification of I, II or III
Who cannot join
- Patients with allergies to local anaesthetic
- Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the operation
- BMI > 40
- Extremes of stature (145cm > Height >210cm)
- Patients with co-existing coagulopathy
- Patients refusing spinal anaesthetic or regional block
Show all 10Show fewer
- Revision hip arthroplasty
- Contraindications to spinal anaesthetic
- Unsatisfactory confirmation of the local anaesthetic spread in the interfascial plane
- Patients requiring transfusion > 2 units of Red Packed Cells in the postoperative period
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care
Gdansk, 80-214
About this study
Official title: Quadratus Lumborum Block in Total Hip Arthroplasty - Effect on Analgesia and Early Physiotherapy: a Randomised Controlled Trial
Currently there is no consensus on the optimal peripheral nerve block for Total Hip Arthroplasty (THA). Furthermore, there is a gap in the literature in regard to the efficacy of Quadratus Lumborum Block (QLB) for Total Hip Arthroplasty via posterior approach.
This Randomised Controlled Trial aims to examine the effectiveness of anterior QLB in patients undergoing Total Hip Arthroplasty via posterior approach. The investigators hypothesise that anterior QLB and spinal anaesthesia is superior to spinal anaesthesia alone with reference to analgesic efficacy and functional ability to engage with physiotherapy in the first 24 hours postoperatively.
Read the detailed description
Adequate analgesic strategies for Total Hip Arthroplasty (THA) are of paramount importance in early rehabilitation and enhanced recovery. Ultrasound guided peripheral nerve blocks emerge as the key element of multi-modal analgesia in modern orthopaedic surgery, but in this setting, given the complex sensory innervation of the hip joint, the optimal regional technique for THA is yet to be elucidated. Many centres incorporate Suprainguinal Fascia Iliaca Block in their THA regimen. Although it confers certain benefits, its analgesic efficacy may be suboptimal for posterior approach THA, especially with regards to dermatomal sensory distribution. The Quadratus Lumborum Block (QLB) is a relatively novel technique, yet its role is already established in providing somatic and visceral analgesia for abdominal and pelvic surgery. There are case reports indicating its utility in THA; Adhikary et al. report that QLB is non inferior to Lumbar Plexus Block in terms of its analgesic efficacy, while being easier to perform and carrying less risks.
There remains some debate regarding the QLB mechanism of action. Its clinical effect may be attributed to the spread to thoracic and lumbar paravertebral spaces, spread within the thoracolumbar fascia or even direct spread to the lumbar plexus branches; perhaps all three mechanisms are involved. Thus, QLB is biologically plausible to provide analgesia without significant motor block for posterior approach THA, but for that purpose, neither the optimal volume of local anaesthetic nor the site of injection (anterior vs posterior vs lateral QLB or the vertical height of injection endpoint) have been established in the literature. Based on the available evidence, as well as experience at our institution, the investigators hypothesise, that in patients undergoing THA via posterior approach, anterior QLB at L4 level using 30 ml 0,5% ropivacaine, 100mcg dexmedetomidine and 1:200,000 adrenaline will reduce movement pain scores within the first 24hours, without clinically significant motor block.
The participants will be randomised into one of two groups using an internet based randomisation tool (https://www.randomizer.org/), and subsequently allocated to either group, with the allocation concealed in a sealed opaque envelope.
- Conditions
- Total Hip Arthroplasty
- Being tested
- anterior Quadratus Lumborum Block, Standard of Care
- Keywords
- Quadratus Lumborum Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior Quadratus Lumborum BlockProcedure or surgery
Also called TQL, Transmuscular QLB, QLB 3
Interfascial plane block
Standard of CareProcedure or surgery
No QLB
| Study group | Role | What they receive |
|---|---|---|
| anterior Quadratus Lumborum Block (QLB) | Experimental | Anterior QLB will be performed in the sitting position. This block is also known as TQL- Transmuscular QLB or QLB 3. A convex transducer will be placed in a transverse position, in the posterior axillary line and tilted caudad until the 'shamrock sign' at L4 level will be obtained. An 80-110 mm SonoTAP (PAJUNK Medizintechnologie, Geisingen, Germany) will be inserted in-plane from the lateral end of the transducer and advanced until the needle tip will be inside the interfascial plane between the Quadratus Lumborum and the Psoas muscles. The successful needle placement will be confirmed by observing the spread of 5 mls 0,9%NaCl. Subsequently, 30 ml 0.5% ropivacaine with 100 mcg dexmedetomidine and adrenaline 1:200,000 will be injected. Satisfactory interfascial spread will be assessed by longitudinal probe orientation.
Following QLB, a spinal anaesthetic will be sited and a THA via posterior approach will be performed. Receives: Procedure: anterior Quadratus Lumborum Block |
| Standard of Care (no QLB) | Active comparator | A spinal anaesthetic will be sited and a THA via posterior approach will be performed. Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score during mobility assessment with physiotherapist
Postoperative movement pain score using an 11-point Numeric Rating Scale (NRS) (0- no pain; 10- the worst pain imaginable) during the first postoperative mobility assessment by physiotherapist
Measured: 24 hours
Secondary outcomes (11)
Serial postoperative NRS pain scores (rest and movement)
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain (0- no pain; 10- the worst pain imaginable). The investigators will record pain score at rest at the specified time intervals; except at 6 hours after intervention (block sited), when the pain score will be recorded simultaneously with hip range of motion assessment
Measured: Time Frame: 3 hours after intervention. 6 hours after intervention. At 22:00 hour on Day 0. At 6:00 hour on Day 1. 36 hours after intervention
Opioid consumption
Opioid consumption (oxycodone)
Measured: 48 hours
Time to first request for rescue opioid analgesia
Time to first request for a rescue opioid administration (PRN oxycodone)
Measured: 48 hours
Ability to ambulate with physiotherapist
Distance in metres will be recorded during the first attempt to ambulate with physiotherapist (usually on Day 1)
Measured: up to 24 hours
Operated limb sensory block
The level of sensory block (to cold temperature), tested with cold spray, will be recorded by a trained assessor on the dermatome map chart.
Measured: 6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)
Operated limb muscle weakness
QLB's effect on muscles involved in hip joint movement will be evaluated. Additionally, muscles innervated by major motor nerves originating in the Lumbar and Sacral plexuses will be examined. The investigators will test patient's ability to perform the motor tasks below, using a 6-point Oxford scale (0 represents no muscle movement and 5 corresponds to normal strength):
hip abduction, straight leg raise, heel slide, knee extension (while supporting the knee under the popliteal fossa), foot plantar flexion, foot dorsal flexion.
Measured: 6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)
Total operation time
Start to end of the recorded anaesthesia time (that includes the operation time)
Measured: During the expected duration of anaesthesia and surgery, which is on average 3 hours
Length of Stay in Recovery area
Length of Stay in Recovery area in minutes
Measured: Expected 30 minutes to 3 hours
The incidence of nausea and/or vomiting
The incidence of nausea and/or vomiting (the total number recorded)
Measured: 48 hours
Patient satisfaction with anaesthesia
Patient satisfaction with anaesthesia data will be collected on discharge from hospital on a scale of 0-4 (0=very dissatisfied, 4= very satisfied)
Measured: up to 6 days
Overall patient satisfaction
Overall patient satisfaction data will be collected on discharge from hospital on a scale of 0-4 (0=very dissatisfied, 4= very satisfied)
Measured: up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start14 May 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: unable to recruit patients due to COVID19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- * Procedure: Quadratus Lumborum Block (QLB) Ultrasound guided Quadratus Lumborum block using an anterior approach. (QLB3; TQL-Transmuscular Quadratus Lumborum) * Procedure: Standard of Care (no QLB)
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Owczuk, Medical University of Gdansk
- Investigators
- Maciej Kaminski, Principal investigator, Medical University of Gdańsk, University Clinical Centre, Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945630
- Sponsor's protocol ID
- MK-1
- Status last verified
- Apr 2020
- First submitted
- 8 May 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block in Total Hip Arthroplasty - Effect on Analgesia and Early Physiotherapy: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03945630
- Acronym / sponsor ID
- MK-1
- Conditions
- Total Hip Arthroplasty
- Keywords
- Quadratus Lumborum Block
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: unable to recruit patients due to COVID19
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 10 May 2019 (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.
Currently there is no consensus on the optimal peripheral nerve block for Total Hip Arthroplasty (THA). Furthermore, there is a gap in the literature in regard to the efficacy of Quadratus Lumborum Block (QLB) for Total Hip Arthroplasty via posterior approach.
This Randomised Controlled Trial aims to examine the effectiveness of anterior QLB in patients undergoing Total Hip Arthroplasty via posterior approach. The investigators hypothesise that anterior QLB and spinal anaesthesia is superior to spinal anaesthesia alone with reference to analgesic efficacy and functional ability to engage with physiotherapy in the first 24 hours postoperatively.
Detailed description
Adequate analgesic strategies for Total Hip Arthroplasty (THA) are of paramount importance in early rehabilitation and enhanced recovery. Ultrasound guided peripheral nerve blocks emerge as the key element of multi-modal analgesia in modern orthopaedic surgery, but in this setting, given the complex sensory innervation of the hip joint, the optimal regional technique for THA is yet to be elucidated. Many centres incorporate Suprainguinal Fascia Iliaca Block in their THA regimen. Although it confers certain benefits, its analgesic efficacy may be suboptimal for posterior approach THA, especially with regards to dermatomal sensory distribution. The Quadratus Lumborum Block (QLB) is a relatively novel technique, yet its role is already established in providing somatic and visceral analgesia for abdominal and pelvic surgery. There are case reports indicating its utility in THA; Adhikary et al. report that QLB is non inferior to Lumbar Plexus Block in terms of its analgesic efficacy, while being easier to perform and carrying less risks.
There remains some debate regarding the QLB mechanism of action. Its clinical effect may be attributed to the spread to thoracic and lumbar paravertebral spaces, spread within the thoracolumbar fascia or even direct spread to the lumbar plexus branches; perhaps all three mechanisms are involved. Thus, QLB is biologically plausible to provide analgesia without significant motor block for posterior approach THA, but for that purpose, neither the optimal volume of local anaesthetic nor the site of injection (anterior vs posterior vs lateral QLB or the vertical height of injection endpoint) have been established in the literature. Based on the available evidence, as well as experience at our institution, the investigators hypothesise, that in patients undergoing THA via posterior approach, anterior QLB at L4 level using 30 ml 0,5% ropivacaine, 100mcg dexmedetomidine and 1:200,000 adrenaline will reduce movement pain scores within the first 24hours, without clinically significant motor block.
The participants will be randomised into one of two groups using an internet based randomisation tool (https://www.randomizer.org/), and subsequently allocated to either group, with the allocation concealed in a sealed opaque envelope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- * Procedure: Quadratus Lumborum Block (QLB) Ultrasound guided Quadratus Lumborum block using an anterior approach. (QLB3; TQL-Transmuscular Quadratus Lumborum) * Procedure: Standard of Care (no QLB)
| Arm | Type | Receives |
|---|---|---|
| anterior Quadratus Lumborum Block (QLB) | Experimental | Procedure: anterior Quadratus Lumborum BlockAnterior QLB will be performed in the sitting position. This block is also known as TQL- Transmuscular QLB or QLB 3. A convex transducer will be placed in a transverse position, in the posterior axillary line and tilted caudad until the 'shamrock sign' at L4 level will be obtained. An 80-110 mm SonoTAP (PAJUNK Medizintechnologie, Geisingen, Germany) will be inserted in-plane from the lateral end of the transducer and advanced until the needle tip will be inside the interfascial plane between the Quadratus Lumborum and the Psoas muscles. The successful needle placement will be confirmed by observing the spread of 5 mls 0,9%NaCl. Subsequently, 30 ml 0.5% ropivacaine with 100 mcg dexmedetomidine and adrenaline 1:200,000 will be injected. Satisfactory interfascial spread will be assessed by longitudinal probe orientation. Following QLB, a spinal anaesthetic will be sited and a THA via posterior approach will be performed. |
| Standard of Care (no QLB) | Active comparator | Procedure: Standard of CareA spinal anaesthetic will be sited and a THA via posterior approach will be performed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing unilateral total hip arthroplasty
- Adults 18 - 90 years.
- ASA classification of I, II or III
Key exclusion criteria (10 listed)
- Patients with allergies to local anaesthetic
- Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the operation
- BMI > 40
- Extremes of stature (145cm > Height >210cm)
- Patients with co-existing coagulopathy
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 Lumborum BlockAlso: TQL, Transmuscular QLB, QLB 3Interfascial plane block | Procedure or surgery | anterior Quadratus Lumborum Block (QLB) |
| Standard of CareNo QLB | Procedure or surgery | Standard of Care (no QLB) |
Primary outcome
NRS score during mobility assessment with physiotherapist
Time frame: 24 hours
Postoperative movement pain score using an 11-point Numeric Rating Scale (NRS) (0- no pain; 10- the worst pain imaginable) during the first postoperative mobility assessment by physiotherapist
11 secondary outcomes
Serial postoperative NRS pain scores (rest and movement)
Time frame: Time Frame: 3 hours after intervention. 6 hours after intervention. At 22:00 hour on Day 0. At 6:00 hour on Day 1. 36 hours after intervention
Opioid consumption
Time frame: 48 hours
Time to first request for rescue opioid analgesia
Time frame: 48 hours
Ability to ambulate with physiotherapist
Time frame: up to 24 hours
Operated limb sensory block
Time frame: 6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)
Operated limb muscle weakness
Time frame: 6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)
Total operation time
Time frame: During the expected duration of anaesthesia and surgery, which is on average 3 hours
Length of Stay in Recovery area
Time frame: Expected 30 minutes to 3 hours
The incidence of nausea and/or vomiting
Time frame: 48 hours
Patient satisfaction with anaesthesia
Time frame: up to 6 days
Overall patient satisfaction
Time frame: up to 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Maciej Kaminski principal investigator
Medical University of Gdańsk, University Clinical Centre, Gdansk
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 Lumborum Block in people with Total Hip Arthroplasty, run by Medical University of Gdansk at 1 site in Poland.
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 10 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: paused, as of the sponsor's last update on 6 Apr 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 Poland. 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?
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?
NRS score during mobility assessment with physiotherapist (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 6 Apr 2020.