Postoperative PainNCT05998954
QLESP Block in Hip Surgery
A study testing transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block and suprainguinal fascia iliaca block in people with Postoperative Pain, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Total hip arthroplasty (THA) is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Regional analgesia techniques are critical components of an optimal multimodal analgesia technique for THA, as they have been shown to improve pain relief as well as reduce… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block and suprainguinal fascia iliaca block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2023to 20 Oct 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18-65 yrs 2. American Society of Anesthesiologists classification 1-3 3. Body mass index between 20 and 35 (kg/m2) 4. Undergo elective primary unilateral THA via a posterolateral approach 5. Informed consent
Who cannot join
- 1. A known allergy to the drugs being used 2. Pre-existing neuropsychiatric disorders or language barrier 3. Analgesics intake, history of substance abuse 4. Contraindications to peripheral nerve block 5. Acute cerebrovascular disease 6. Severe liver failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: QLESP Block for Postoperative Analgesia in Hip Surgery
Total hip arthroplasty (THA) is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Regional analgesia techniques are critical components of an optimal multimodal analgesia technique for THA, as they have been shown to improve pain relief as well as reduce opioid requirements. Ultrasound-guided suprainguinal fascia iliaca (SFI) block has been recommended as a reliable analgesic option for THA. However, SFI block may lead to decreased motor strength of the surgical limb thereby hindering postoperative mobilization. Recently, our group has developed a novel transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block, which is characterized by simple operation, high efficiency, and wide dermatomal coverage of sensory block. In this randomized trial, we aimed to compare ultrasound-guided QLESP with SFI block as a component of non-opioid analgesic regimen in patients undergoing THA. The primary outcome of the study was postoperative sufentanil consumption within the initial 24-h postoperative period after THA. The secondary objectives were to compare pain scores, postoperative quadriceps strength, the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and the time to hospital discharge.
- Conditions
- Postoperative Pain
- Being tested
- transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block, suprainguinal fascia iliaca 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.
transmuscular quadratus lumborum and modified erector spinae plane (QLESP) blockProcedure or surgery
Fifteen ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. Fifteen ml of 0.375% ropivacaine was subsequently given between the quadratus lumborum and the psoas major muscles.
suprainguinal fascia iliaca blockProcedure or surgery
Thirty ml of 0.375% ropivacaine will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.
| Study group | Role | What they receive |
|---|---|---|
| Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group) | Experimental | The patient was turned to the lateral decubitus position with the side to be blocked upward and a low-frequency curved array transducer was placed on the flank cranially to the iliac crest to identify the transverse process of L4, quadratus lumborum muscle, erector spinae muscle, and psoas muscle. The needle was advanced to gently contact the transverse process using an in-plane technique and 15 ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. The needle was subsequently withdrawn and redirected toward the interfascial plane between the quadratus lumborum and the psoas major muscles, where 15 ml of 0.375% ropivacaine was injected with repeated negative aspiration. Receives: Procedure: transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block |
| Suprainguinal fascia iliaca block (SFI group) | Active comparator | With the patient in the supine position, the ultrasound transducer was placed in a parasagittal orientation over the inguinal ligament, inferior medially to the anterior superior iliac spine. Using real-time ultrasound imaging internal oblique, sartorius and iliacus muscles, covered by the fascia iliacus, were identified. With the needle tip placed beneath the fascia and above the iliacus muscle from caudad-to-cephalad direction (in-plane technique), 30 ml of 0.375% ropivacaine was injected slowly to separate the fascia iliaca from the iliacus muscle. Receives: Procedure: suprainguinal fascia iliaca block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative opioid consumption
Measured: At 24 postoperative hours
Secondary outcomes (6)
The pain scores determined by the numeric rating scale (NRS, 0-10)
Measured: At 1, 6, 12, 24, and 48 hours after the surgery
Quadriceps strength
Measured: At 1, 6, 12, 24, and 48 hours after the surgery
The time to first rescue analgesia
Measured: Within postoperative 48 hours
Postoperative hospital length of stay
Measured: Up to 6 weeks
The Time to Ambulation
Measured: Postoperative 48 hours
Adverse events
Measured: Postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start22 Aug 2023
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Why it stopped: No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Wu, Huazhong University of Science and Technology
- Investigators
- Xi Wu, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998954
- Sponsor's protocol ID
- XH20230812
- Status last verified
- Nov 2023
- First submitted
- 13 Aug 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu X, Yang L. Quadratus Lumborum and modified Erector Spinae Plane (QLESP) block: A single-puncture technique for total hip arthroplasty. J Clin Anesth. 2020 May;61:109643. doi: 10.1016/j.jclinane.2019.109643. Epub 2019 Oct 23. No abstract available.
PubMed 31668470
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QLESP Block for Postoperative Analgesia in Hip Surgery
- ClinicalTrials.gov ID
- NCT05998954
- Acronym / sponsor ID
- XH20230812
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 21 Aug 2023 (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.
Total hip arthroplasty (THA) is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Regional analgesia techniques are critical components of an optimal multimodal analgesia technique for THA, as they have been shown to improve pain relief as well as reduce opioid requirements. Ultrasound-guided suprainguinal fascia iliaca (SFI) block has been recommended as a reliable analgesic option for THA. However, SFI block may lead to decreased motor strength of the surgical limb thereby hindering postoperative mobilization. Recently, our group has developed a novel transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block, which is characterized by simple operation, high efficiency, and wide dermatomal coverage of sensory block. In this randomized trial, we aimed to compare ultrasound-guided QLESP with SFI block as a component of non-opioid analgesic regimen in patients undergoing THA. The primary outcome of the study was postoperative sufentanil consumption within the initial 24-h postoperative period after THA. The secondary objectives were to compare pain scores, postoperative quadriceps strength, the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and the time to hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group) | Experimental | Procedure: transmuscular quadratus lumborum and modified erector spinae plane (QLESP) blockThe patient was turned to the lateral decubitus position with the side to be blocked upward and a low-frequency curved array transducer was placed on the flank cranially to the iliac crest to identify the transverse process of L4, quadratus lumborum muscle, erector spinae muscle, and psoas muscle. The needle was advanced to gently contact the transverse process using an in-plane technique and 15 ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. The needle was subsequently withdrawn and redirected toward the interfascial plane between the quadratus lumborum and the psoas major muscles, where 15 ml of 0.375% ropivacaine was injected with repeated negative aspiration. |
| Suprainguinal fascia iliaca block (SFI group) | Active comparator | Procedure: suprainguinal fascia iliaca blockWith the patient in the supine position, the ultrasound transducer was placed in a parasagittal orientation over the inguinal ligament, inferior medially to the anterior superior iliac spine. Using real-time ultrasound imaging internal oblique, sartorius and iliacus muscles, covered by the fascia iliacus, were identified. With the needle tip placed beneath the fascia and above the iliacus muscle from caudad-to-cephalad direction (in-plane technique), 30 ml of 0.375% ropivacaine was injected slowly to separate the fascia iliaca from the iliacus muscle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age 18-65 yrs 2. American Society of Anesthesiologists classification 1-3 3. Body mass index between 20 and 35 (kg/m2) 4. Undergo elective primary unilateral THA via a posterolateral approach 5. Informed consent
Key exclusion criteria (1 listed)
- 1. A known allergy to the drugs being used 2. Pre-existing neuropsychiatric disorders or language barrier 3. Analgesics intake, history of substance abuse 4. Contraindications to peripheral nerve block 5. Acute cerebrovascular disease 6. Severe liver failure
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 |
|---|---|---|
| transmuscular quadratus lumborum and modified erector spinae plane (QLESP) blockFifteen ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. Fifteen ml of 0.375% ropivacaine was subsequently given between the quadratus lumborum and the psoas major muscles. | Procedure or surgery | Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group) |
| suprainguinal fascia iliaca blockThirty ml of 0.375% ropivacaine will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle. | Procedure or surgery | Suprainguinal fascia iliaca block (SFI group) |
Primary outcome
The cumulative opioid consumption
Time frame: At 24 postoperative hours
6 secondary outcomes
The pain scores determined by the numeric rating scale (NRS, 0-10)
Time frame: At 1, 6, 12, 24, and 48 hours after the surgery
Quadriceps strength
Time frame: At 1, 6, 12, 24, and 48 hours after the surgery
The time to first rescue analgesia
Time frame: Within postoperative 48 hours
Postoperative hospital length of stay
Time frame: Up to 6 weeks
The Time to Ambulation
Time frame: Postoperative 48 hours
Adverse events
Time frame: Postoperative 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 31668470Wu X, Yang L. Quadratus Lumborum and modified Erector Spinae Plane (QLESP) block: A single-puncture technique for total hip arthroplasty. J Clin Anesth. 2020 May;61:109643. doi: 10.1016/j.jclinane.2019.109643. Epub 2019 Oct 23. No abstract available.
- 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.
Xi Wu principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block and suprainguinal fascia iliaca block in people with Postoperative Pain, 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 7 Nov 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The cumulative opioid consumption (time frame: At 24 postoperative 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 NCT05998954, which also lists 1 linked publication.
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 7 Nov 2023.