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

Not Applicable

Completed

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

• Registration Number: NCT04266236
• Lead Sponsor: Shanghai 6th People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Study Start: 2020-07-09
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T12 combined with L3 and L4 LPB technique (TP group)	L4 LPB	ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique
L3 LPB technique (P group)	General anesthesia with tracheal intubation	ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique
T12 combined with L3 and L4 LPB technique (TP group)	L3 LPB	ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique
T12 combined with L3 and L4 LPB technique (TP group)	T12 block	ultrasound-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)	0.375%ropivacaine 40 ml (Raropin)	ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique
L3 LPB combined with QLB (LPQLB-SNT, PQ group)	General anesthesia with tracheal intubation	ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique
L3 LPB technique (P group)	0.375%ropivacaine 25 ml (Raropin)	ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique
L3 LPB technique (P group)	L3 LPB	ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique
T12 combined with L3 and L4 LPB technique (TP group)	General anesthesia with tracheal intubation	ultrasound-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)	L3 LPB	ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique
T12 combined with L3 and L4 LPB technique (TP group)	0.375%ropivacaine 40 ml (Raropin)	ultrasound-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)	L3 QLB	ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique

Primary Outcome Measures

Name	Time	Method
sensory block assessment	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

Name	Time	Method
Cumulative doses of intraoperative vasoactive medications	during the operation	Cumulative doses of intraoperative vasoactive medications (urapidil, atropine, ephedrine and deoxyepinephrine, etc.)
postoperative static pain at timepoint 2	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
postoperative static pain at timepoint 1	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
postoperative static pain at timepoint 3	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
postoperative static pain at timepoint 4	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
Incidence of block related adverse events	within 24hours after nerve block procedure	Intraoperative and postoperative adverse events such as vascular puncture, local anesthetic systemic toxicity, epidural spread, etc.
Performance time of block	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
intraoperative sufentanil dosage	during the operation	The total intraoperative sufentanil dosage will be recorded

Trial Locations

Locations (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China