Hip OsteoarthritisLPQLB-SNTNCT04266236
LPB Combined with QLB Using Single-needle Technique (LPQLB-SNT) for Hip Arthroplasty
A study testing L3 LPB, L4 LPB and T12 block in people with Hip Osteoarthritis and Anesthesia, Local, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Total hip arthroplasty (THA) is one of the most successful orthopedic procedures to effectively relieve pain and restore function in patients with hip osteoarthritis, osteonecrosis of femoral head and hip fracture.The Lumbar Plexus Block (LPB) is currently used as the standard regional anesthesia technique to provide… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Osteoarthritis, Anesthesia, Local, Hip Fractures
- What is being tested?
- L3 LPB, L4 LPB and T12 block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2020to 30 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 30kg/m2 and the weight ≥50kg
- American Society of Anesthesiologists (ASA) classification I-II
- Postero-lateral operative incision approach unilateral hip arthroplasty
- Aged 18-75
Who cannot join
- Patient refusal
- Patients with coagulopathy or on therapeutic anticoagulation
- Pregnancy
- Multiple trauma
- Hypersensitivity or allergy to ropivacaine
- History of ankylosing spondylitis or spinal surgery
- Lower extremity neuropathy
- Unable to communicate
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: Ultrasound-guided Lumbar Plexus Combined with Quadratus Lumborum Block Using Single-needle Technique with Shamrock Method for Hip Arthroplasty
Total hip arthroplasty (THA) is one of the most successful orthopedic procedures to effectively relieve pain and restore function in patients with hip osteoarthritis, osteonecrosis of femoral head and hip fracture.The Lumbar Plexus Block (LPB) is currently used as the standard regional anesthesia technique to provide postoperative pain management after THA. The lumbar plexus (LP) originates from T12 to L5. In general, multiple-needle nerve blockade procedure is needed to block different branches of LP. Therefore, we need more time to finish the regional anethesia procedure and it's not easy for an inexperienced anesthesiologist to master the technique absolutely. In addition, multiple injections will increase the discomfort of the patients. We aim to investigate the effects of lumbar plexus combined with quadratus lumborum block using single-needle technique with Shamrock method as an alternative regional anesthesia.
- Being tested
- L3 LPB, L4 LPB, T12 block, L3 QLB, 0.375%ropivacaine 25 ml (Raropin)
- Keywords
- lumbar plexus block, quadratus lumorum block, total hip arthroplasty, single-needle, shamrock approach
- Medical subject headings
- Osteoarthritis, Hip, Hip Fractures, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L3 LPBProcedure or surgery
ultrasound-guided L3 lumbar plexus block
L4 LPBProcedure or surgery
ultrasound-guided L4 lumbar plexus block
T12 blockProcedure or surgery
ultrasound-guided thoracic 12th segment nerve block
L3 QLBProcedure or surgery
ultrasound-guided quadratus lumborum block at L3 level
0.375%ropivacaine 25 ml (Raropin)Drug
0.375%ropivacaine (Raropin) 25ml will be given
0.375%ropivacaine 40 ml (Raropin)Drug
0.375%ropivacaine (Raropin) 40ml will be given
General anesthesia with tracheal intubationProcedure or surgery
General anesthesia with tracheal intubation will be induced with sufentanil, propofol, vecuronium for every patient before the operation and maintained with sevoflurane during the operation
| Study group | Role | What they receive |
|---|---|---|
| L3 LPB technique (P group) | Active comparator | ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique Receives: Procedure: L3 LPB; Drug: 0.375%ropivacaine 25 ml (Raropin); Procedure: General anesthesia with tracheal intubation |
| T12 combined with L3 and L4 LPB technique (TP group) | Active comparator | ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique Receives: Procedure: L3 LPB; Procedure: L4 LPB; Procedure: T12 block; Drug: 0.375%ropivacaine 40 ml (Raropin); Procedure: General anesthesia with tracheal intubation |
| L3 LPB combined with QLB (LPQLB-SNT, PQ group) | Experimental | ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique Receives: Procedure: L3 LPB; Procedure: L3 QLB; Drug: 0.375%ropivacaine 40 ml (Raropin); Procedure: General anesthesia with tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory block assessment
The sensory block will be assessed by cold alcohol swab and pinprick at lateral, anterior and medial areas of thigh and postero-lateral area of gluteus using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.
Measured: 30 minutes after nerve block procedure
Secondary outcomes (8)
postoperative static pain at timepoint 1
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest will be recorded at several points of time within 24 hours after surgery: 1) 30mins after the patient recover from general anesthesia in postanesthesia care unit (PACU); 2) 6 hours after surgery;3) 12 hours after surgery; 4) 24 hours after surgery
Measured: at 30mins after the patient recover from general anesthesia
postoperative static pain at timepoint 2
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest will be recorded at several points of time within 24 hours after surgery: 1) 30mins after the patient recover from general anesthesia in postanesthesia care unit (PACU); 2) 6 hours after surgery;3) 12 hours after surgery; 4) 24 hours after surgery
Measured: at 6 hours after surgery
postoperative static pain at timepoint 3
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest will be recorded at several points of time within 24 hours after surgery: 1) 30mins after the patient recover from general anesthesia in postanesthesia care unit (PACU); 2) 6 hours after surgery;3) 12 hours after surgery; 4) 24 hours after surgery
Measured: at 12 hours after surgery
postoperative static pain at timepoint 4
Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest will be recorded at several points of time within 24 hours after surgery: 1) 30mins after the patient recover from general anesthesia in postanesthesia care unit (PACU); 2) 6 hours after surgery;3) 12 hours after surgery; 4) 24 hours after surgery
Measured: at 24 hours after surgery
Performance time of block
Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection
Measured: During nerve block procedure
intraoperative sufentanil dosage
The total intraoperative sufentanil dosage will be recorded
Measured: during the operation
Incidence of block related adverse events
Intraoperative and postoperative adverse events such as vascular puncture, local anesthetic systemic toxicity, epidural spread, etc.
Measured: within 24hours after nerve block procedure
Cumulative doses of intraoperative vasoactive medications
Cumulative doses of intraoperative vasoactive medications (urapidil, atropine, ephedrine and deoxyepinephrine, etc.)
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start9 Jul 2020
- Primary completion31 May 2024
- Study completion30 Jun 2024
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 Hip OsteoarthritisStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng WANG, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266236
- Sponsor's protocol ID
- 2020-031
- Acronym
- LPQLB-SNT
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2020
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data with patient identification will not be publicly accessible after the study.
Publications
Wang X, Zhang J, Xie Z, Chen Y, Yonglin-Chen, Rao Z, Zhang H. Efficacy and safety of combined lumbar plexus and quadratus lumborum block via Shamrock approach at L3 in total hip arthroplasty: a prospective randomized controlled trial. Trials. 2025 Nov 4;26(1):467. doi: 10.1186/s13063-025-09195-w.
PubMed 41188948Wang X, Zhang H, Chen Y, Xie Z, Chen M, Chen Y, Zhang J. The anesthetic efficacy of ultrasound-guided lumbar plexus combined with quadratus lumborum block with Shamrock approach in total hip arthroplasty: study protocol for a randomized controlled trial. Trials. 2023 Sep 18;24(1):596. doi: 10.1186/s13063-023-07619-z.
PubMed 37718446
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Lumbar Plexus Combined with Quadratus Lumborum Block Using Single-needle Technique with Shamrock Method for Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04266236
- Acronym / sponsor ID
- LPQLB-SNT / 2020-031
- Keywords
- lumbar plexus block, quadratus lumorum block, total hip arthroplasty, single-needle, shamrock approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Feb 2020 (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 one of the most successful orthopedic procedures to effectively relieve pain and restore function in patients with hip osteoarthritis, osteonecrosis of femoral head and hip fracture.The Lumbar Plexus Block (LPB) is currently used as the standard regional anesthesia technique to provide postoperative pain management after THA. The lumbar plexus (LP) originates from T12 to L5. In general, multiple-needle nerve blockade procedure is needed to block different branches of LP. Therefore, we need more time to finish the regional anethesia procedure and it's not easy for an inexperienced anesthesiologist to master the technique absolutely. In addition, multiple injections will increase the discomfort of the patients. We aim to investigate the effects of lumbar plexus combined with quadratus lumborum block using single-needle technique with Shamrock method as an alternative regional anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L3 LPB technique (P group) | Active comparator | Procedure: L3 LPB, Drug: 0.375%ropivacaine 25 ml (Raropin), Procedure: General anesthesia with tracheal intubationultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique |
| T12 combined with L3 and L4 LPB technique (TP group) | Active comparator | Procedure: L3 LPB, Procedure: L4 LPB, Procedure: T12 block, Drug: 0.375%ropivacaine 40 ml (Raropin), Procedure: General anesthesia with tracheal intubationultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique |
| L3 LPB combined with QLB (LPQLB-SNT, PQ group) | Experimental | Procedure: L3 LPB, Procedure: L3 QLB, Drug: 0.375%ropivacaine 40 ml (Raropin), Procedure: General anesthesia with tracheal intubationultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 18.5 and 30kg/m2 and the weight ≥50kg
- American Society of Anesthesiologists (ASA) classification I-II
- Postero-lateral operative incision approach unilateral hip arthroplasty
- Aged 18-75
Key exclusion criteria (8 listed)
- Patient refusal
- Patients with coagulopathy or on therapeutic anticoagulation
- Pregnancy
- Multiple trauma
- Hypersensitivity or allergy to ropivacaine
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 |
|---|---|---|
| L3 LPBultrasound-guided L3 lumbar plexus block | Procedure or surgery | L3 LPB combined with QLB (LPQLB-SNT, PQ group), L3 LPB technique (P group), T12 combined with L3 and L4 LPB technique (TP group) |
| L4 LPBultrasound-guided L4 lumbar plexus block | Procedure or surgery | T12 combined with L3 and L4 LPB technique (TP group) |
| T12 blockultrasound-guided thoracic 12th segment nerve block | Procedure or surgery | T12 combined with L3 and L4 LPB technique (TP group) |
| L3 QLBultrasound-guided quadratus lumborum block at L3 level | Procedure or surgery | L3 LPB combined with QLB (LPQLB-SNT, PQ group) |
| 0.375%ropivacaine 25 ml (Raropin)0.375%ropivacaine (Raropin) 25ml will be given | Drug | L3 LPB technique (P group) |
| 0.375%ropivacaine 40 ml (Raropin)0.375%ropivacaine (Raropin) 40ml will be given | Drug | L3 LPB combined with QLB (LPQLB-SNT, PQ group), T12 combined with L3 and L4 LPB technique (TP group) |
| General anesthesia with tracheal intubationGeneral anesthesia with tracheal intubation will be induced with sufentanil, propofol, vecuronium for every patient before the operation and maintained with sevoflurane during the operation | Procedure or surgery | L3 LPB combined with QLB (LPQLB-SNT, PQ group), L3 LPB technique (P group), T12 combined with L3 and L4 LPB technique (TP group) |
Primary outcome
sensory block assessment
Time frame: 30 minutes after nerve block procedure
The sensory block will be assessed by cold alcohol swab and pinprick at lateral, anterior and medial areas of thigh and postero-lateral area of gluteus using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.
8 secondary outcomes
postoperative static pain at timepoint 1
Time frame: at 30mins after the patient recover from general anesthesia
postoperative static pain at timepoint 2
Time frame: at 6 hours after surgery
postoperative static pain at timepoint 3
Time frame: at 12 hours after surgery
postoperative static pain at timepoint 4
Time frame: at 24 hours after surgery
Performance time of block
Time frame: During nerve block procedure
intraoperative sufentanil dosage
Time frame: during the operation
Incidence of block related adverse events
Time frame: within 24hours after nerve block procedure
Cumulative doses of intraoperative vasoactive medications
Time frame: during the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 41188948Wang X, Zhang J, Xie Z, Chen Y, Yonglin-Chen, Rao Z, Zhang H. Efficacy and safety of combined lumbar plexus and quadratus lumborum block via Shamrock approach at L3 in total hip arthroplasty: a prospective randomized controlled trial. Trials. 2025 Nov 4;26(1):467. doi: 10.1186/s13063-025-09195-w.
- Derived from this study: PubMed 37718446Wang X, Zhang H, Chen Y, Xie Z, Chen M, Chen Y, Zhang J. The anesthetic efficacy of ultrasound-guided lumbar plexus combined with quadratus lumborum block with Shamrock approach in total hip arthroplasty: study protocol for a randomized controlled trial. Trials. 2023 Sep 18;24(1):596. doi: 10.1186/s13063-023-07619-z.
- Individual participant dataSharing planned: No. Data with patient identification will not be publicly accessible after the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L3 LPB, L4 LPB and T12 block in people with Hip Osteoarthritis and Anesthesia, Local, run by Shanghai 6th People's Hospital 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 10 Feb 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sensory block assessment (time frame: 30 minutes after nerve block procedure). 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 NCT04266236, 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 10 Feb 2025.