LPB Combined With QLB Using Single-needle Technique (LPQLB-SNT) for Hip Arthroplasty (LPQLB-SNT)
Primary Purpose
Hip Osteoarthritis, Anesthesia, Local, Hip Fractures
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
L3 LPB
L4 LPB
T12 block
L3 QLB
0.375%ropivacaine 25 ml (Raropin)
0.375%ropivacaine 40 ml (Raropin)
General anesthesia with tracheal intubation
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring lumbar plexus block, quadratus lumorum block, total hip arthroplasty, single-needle, shamrock approach
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
L3 LPB technique (P group)
T12 combined with L3 and L4 LPB technique (TP group)
L3 LPB combined with QLB (LPQLB-SNT, PQ group)
Arm Description
ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique
ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique
ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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
intraoperative sufentanil dosage
The total intraoperative sufentanil dosage will be recorded
Incidence of block related adverse events
Intraoperative and postoperative adverse events such as vascular puncture, local anesthetic systemic toxicity, epidural spread, etc.
Cumulative doses of intraoperative vasoactive medications
Cumulative doses of intraoperative vasoactive medications (urapidil, atropine, ephedrine and deoxyepinephrine, etc.)
Full Information
NCT ID
NCT04266236
First Posted
February 10, 2020
Last Updated
March 14, 2023
Sponsor
Shanghai 6th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04266236
Brief Title
LPB Combined With QLB Using Single-needle Technique (LPQLB-SNT) for Hip Arthroplasty
Acronym
LPQLB-SNT
Official Title
Ultrasound-guided Lumbar Plexus Combined With Quadratus Lumborum Block Using Single-needle Technique With Shamrock Method for Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Anesthesia, Local, Hip Fractures, Osteonecrosis of Femoral Head
Keywords
lumbar plexus block, quadratus lumorum block, total hip arthroplasty, single-needle, shamrock approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L3 LPB technique (P group)
Arm Type
Active Comparator
Arm Description
ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique
Arm Title
T12 combined with L3 and L4 LPB technique (TP group)
Arm Type
Active Comparator
Arm Description
ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique
Arm Title
L3 LPB combined with QLB (LPQLB-SNT, PQ group)
Arm Type
Experimental
Arm Description
ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique
Intervention Type
Procedure
Intervention Name(s)
L3 LPB
Intervention Description
ultrasound-guided L3 lumbar plexus block
Intervention Type
Procedure
Intervention Name(s)
L4 LPB
Intervention Description
ultrasound-guided L4 lumbar plexus block
Intervention Type
Procedure
Intervention Name(s)
T12 block
Intervention Description
ultrasound-guided thoracic 12th segment nerve block
Intervention Type
Procedure
Intervention Name(s)
L3 QLB
Intervention Description
ultrasound-guided quadratus lumborum block at L3 level
Intervention Type
Drug
Intervention Name(s)
0.375%ropivacaine 25 ml (Raropin)
Intervention Description
0.375%ropivacaine (Raropin) 25ml will be given
Intervention Type
Drug
Intervention Name(s)
0.375%ropivacaine 40 ml (Raropin)
Intervention Description
0.375%ropivacaine (Raropin) 40ml will be given
Intervention Type
Procedure
Intervention Name(s)
General anesthesia with tracheal intubation
Intervention Description
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
Primary Outcome Measure Information:
Title
sensory block assessment
Description
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.
Time Frame
30 minutes after nerve block procedure
Secondary Outcome Measure Information:
Title
postoperative static pain at timepoint 1
Description
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
Time Frame
at 30mins after the patient recover from general anesthesia
Title
postoperative static pain at timepoint 2
Description
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
Time Frame
at 6 hours after surgery
Title
postoperative static pain at timepoint 3
Description
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
Time Frame
at 12 hours after surgery
Title
postoperative static pain at timepoint 4
Description
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
Time Frame
at 24 hours after surgery
Title
Performance time of block
Description
Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection
Time Frame
During nerve block procedure
Title
intraoperative sufentanil dosage
Description
The total intraoperative sufentanil dosage will be recorded
Time Frame
during the operation
Title
Incidence of block related adverse events
Description
Intraoperative and postoperative adverse events such as vascular puncture, local anesthetic systemic toxicity, epidural spread, etc.
Time Frame
within 24hours after nerve block procedure
Title
Cumulative doses of intraoperative vasoactive medications
Description
Cumulative doses of intraoperative vasoactive medications (urapidil, atropine, ephedrine and deoxyepinephrine, etc.)
Time Frame
during the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaofeng wang
Phone
+8618930170135
Email
240483680@qq.com
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Wang, MD
Phone
+8618930170135
Email
240483680@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data with patient identification will not be publicly accessible after the study.
Learn more about this trial
LPB Combined With QLB Using Single-needle Technique (LPQLB-SNT) for Hip Arthroplasty
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