This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266236
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Xiaofeng WANG, Shanghai 6th People's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Anesthesia, Local Hip Fractures Osteonecrosis of Femoral Head Procedure: L3 LPB Procedure: L4 LPB Procedure: T12 block Procedure: L3 QLB Drug: 0.375%ropivacaine 25 ml (Raropin) Drug: 0.375%ropivacaine 40 ml (Raropin) Procedure: General anesthesia with tracheal intubation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Lumbar Plexus Combined With Quadratus Lumborum Block Using Single-needle Technique With Shamrock Method for Hip Arthroplasty
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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: 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

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
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: L3 QLB
ultrasound-guided quadratus lumborum block at L3 level

Drug: 0.375%ropivacaine 40 ml (Raropin)
0.375%ropivacaine (Raropin) 40ml 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. intraoperative sufentanil dosage [ Time Frame: during the operation ]
    The total intraoperative sufentanil dosage will be recorded

  7. 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.

  8. Cumulative doses of intraoperative vasoactive medications [ Time Frame: during the operation ]
    Cumulative doses of intraoperative vasoactive medications (urapidil, atropine, ephedrine and deoxyepinephrine, etc.)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266236


Contacts
Layout table for location contacts
Contact: xiaofeng wang +8618930170135 240483680@qq.com

Locations
Layout table for location information
China, Shanghai
Shanghai Jiao Tong University Affiliated Sixth People's Hospital Recruiting
Shanghai, Shanghai, China, 200233
Contact: Xiaofeng Wang, MD    +8618930170135    240483680@qq.com   
Sponsors and Collaborators
Shanghai 6th People's Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Xiaofeng WANG, Attending doctor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT04266236    
Other Study ID Numbers: 2020-031
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data with patient identification will not be publicly accessible after the study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaofeng WANG, Shanghai 6th People's Hospital:
lumbar plexus block
quadratus lumorum block
total hip arthroplasty
single-needle
shamrock approach
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Hip
Osteonecrosis
Hip Fractures
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
 Leg Injuries
Bone Diseases
Necrosis
Pathologic Processes
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents