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

Hip Fractures Clinical Trial

— LPQLB-SNT  

Official title:

Ultrasound-guided Lumbar Plexus Combined With Quadratus Lumborum Block Using Single-needle Technique With Shamrock Method for Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04266236
• Other study ID #: 2020-031
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Shanghai 6th People's Hospital
• Contact: xiaofeng wang
• Phone: +8618930170135
• Email: 240483680[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Hip Fractures
• Hip Osteoarthritis
• Osteoarthritis, Hip
• Osteonecrosis
• Osteonecrosis of Femoral Head

Intervention

Procedure:
• L3 LPB
ultrasound-guided L3 lumbar plexus block
• L4 LPB
ultrasound-guided L4 lumbar plexus block
• T12 block
ultrasound-guided thoracic 12th segment nerve block
• L3 QLB
ultrasound-guided quadratus lumborum block at L3 level

Drug:
• 0.375%ropivacaine 25 ml (Raropin)
0.375%ropivacaine (Raropin) 25ml will be given
• 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

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	intraoperative sufentanil dosage	The total intraoperative sufentanil dosage will be recorded	during the operation
Secondary	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
Secondary	Cumulative doses of intraoperative vasoactive medications	Cumulative doses of intraoperative vasoactive medications (urapidil, atropine, ephedrine and deoxyepinephrine, etc.)	during the operation