LPB Combined with QLB Using Single-needle Technique (LPQLB-SNT) for Hip Arthroplasty (LPQLB-SNT)

February 5, 2025 updated by: Xiaofeng WANG, Shanghai 6th People's Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Body mass index (BMI) between 18.5 and 30kg/m2 and the weight ≥50kg
  2. American Society of Anesthesiologists (ASA) classification I-II
  3. Postero-lateral operative incision approach unilateral hip arthroplasty
  4. Aged 18-75

Exclusion Criteria:

  1. Patient refusal
  2. Patients with coagulopathy or on therapeutic anticoagulation
  3. Pregnancy
  4. Multiple trauma
  5. Hypersensitivity or allergy to ropivacaine
  6. History of ankylosing spondylitis or spinal surgery
  7. Lower extremity neuropathy
  8. Unable to communicate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: L3 LPB technique (P group)
ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique
Procedure: L3 LPB
ultrasound-guided L3 lumbar plexus block
Drug: 0.375%ropivacaine 25 ml (Raropin)
0.375%ropivacaine (Raropin) 25ml will be given
Procedure: General anesthesia with tracheal intubation
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
Active Comparator: T12 combined with L3 and L4 LPB technique (TP group)
ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique
Procedure: L3 LPB
ultrasound-guided L3 lumbar plexus block
Procedure: General anesthesia with tracheal intubation
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
Procedure: L4 LPB
ultrasound-guided L4 lumbar plexus block
Procedure: T12 block
ultrasound-guided thoracic 12th segment nerve block
Drug: 0.375%ropivacaine 40 ml (Raropin)
0.375%ropivacaine (Raropin) 40ml will be given
Experimental: L3 LPB combined with QLB (LPQLB-SNT, PQ group)
ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique
Procedure: L3 LPB
ultrasound-guided L3 lumbar plexus block
Procedure: General anesthesia with tracheal intubation
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
Drug: 0.375%ropivacaine 40 ml (Raropin)
0.375%ropivacaine (Raropin) 40ml will be given
Procedure: L3 QLB
ultrasound-guided quadratus lumborum block at L3 level

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 minutes after nerve block procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
postoperative static pain at timepoint 1
Time Frame: at 30mins after the patient recover from general anesthesia
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
at 30mins after the patient recover from general anesthesia
postoperative static pain at timepoint 2
Time Frame: at 6 hours after surgery
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
at 6 hours after surgery
postoperative static pain at timepoint 3
Time Frame: at 12 hours after surgery
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
at 12 hours after surgery
postoperative static pain at timepoint 4
Time Frame: at 24 hours after surgery
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
at 24 hours after surgery
Performance time of block
Time Frame: During nerve block procedure
Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection
During nerve block procedure
intraoperative sufentanil dosage
Time Frame: during the operation
The total intraoperative sufentanil dosage will be recorded
during the operation
Incidence of block related adverse events
Time Frame: within 24hours after nerve block procedure
Intraoperative and postoperative adverse events such as vascular puncture, local anesthetic systemic toxicity, epidural spread, etc.
within 24hours after nerve block procedure
Cumulative doses of intraoperative vasoactive medications
Time Frame: during the operation
Cumulative doses of intraoperative vasoactive medications (urapidil, atropine, ephedrine and deoxyepinephrine, etc.)
during the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai 6th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data with patient identification will not be publicly accessible after the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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