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

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: Recruiting
• Conditions: Anesthesia, Local; Hip Fractures; Hip Osteoarthritis; Osteonecrosis of Femoral Head
• Intervention / Treatment: Procedure: L3 LPB; Drug: 0.375%ropivacaine 25 ml (Raropin); Procedure: General anesthesia with tracheal intubation; Procedure: L4 LPB; Procedure: T12 block; Drug: 0.375%ropivacaine 40 ml (Raropin); Procedure: L3 QLB

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xiaofeng wang; Phone Number: +8618930170135; Email: 240483680@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Recruiting
      • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
      • Contact: Xiaofeng Wang, MD; Phone Number: +8618930170135; Email: 240483680@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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

Outcome Measure	Measure Description	Time Frame
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.	30 minutes after nerve block procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	During nerve block procedure
intraoperative sufentanil dosage	The total intraoperative sufentanil dosage will be recorded	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.	within 24hours after nerve block procedure
Cumulative doses of intraoperative vasoactive medications	Cumulative doses of intraoperative vasoactive medications (urapidil, atropine, ephedrine and deoxyepinephrine, etc.)	during the operation

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: total hip arthroplasty; lumbar plexus block; quadratus lumorum block; single-needle; shamrock approach
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Femoral Fractures; Hip Injuries; Osteoarthritis; Hip Fractures; Osteoarthritis, Hip; Osteonecrosis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID 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