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NCT Number: NCT04266236

LPB Combined with QLB Using Single-needle Technique (LPQLB-SNT) 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.

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Key information

Conditions

Hip Osteoarthritis Anesthesia, Local Arthritis Bone Diseases Femoral Fractures Femur Head Necrosis Fractures, Bone Hip Fractures Hip Injuries Joint Diseases Leg Injuries Musculoskeletal Diseases Necrosis Osteoarthritis Osteoarthritis, Hip Osteonecrosis Osteonecrosis of Femoral Head Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L3 LPB

Procedure

ultrasound-guided L3 lumbar plexus block

L4 LPB

Procedure

ultrasound-guided L4 lumbar plexus block

T12 block

Procedure

ultrasound-guided thoracic 12th segment nerve block

L3 QLB

Procedure

ultrasound-guided quadratus lumborum block at L3 level

0.375%ropivacaine 25 ml (Raropin)

Drug

0.375%ropivacaine (Raropin) 25ml will be given

0.375%ropivacaine 40 ml (Raropin)

Drug

0.375%ropivacaine (Raropin) 40ml will be given

General anesthesia with tracheal intubation

Procedure

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 outcomes

  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 outcomes

  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.)

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study title

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

Acronym: LPQLB-SNT

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2020
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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