NCT04266236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 9, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

3.9 years

First QC Date

February 10, 2020

Last Update Submit

February 5, 2025

Conditions

Keywords

lumbar plexus blockquadratus lumorum blocktotal hip arthroplastysingle-needleshamrock approach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • postoperative static pain at timepoint 1

    at 30mins after the patient recover from general anesthesia

  • postoperative static pain at timepoint 2

    at 6 hours after surgery

  • postoperative static pain at timepoint 3

    at 12 hours after surgery

  • postoperative static pain at timepoint 4

    at 24 hours after surgery

  • Performance time of block

    During nerve block procedure

  • +3 more secondary outcomes

Study Arms (3)

L3 LPB technique (P group)

ACTIVE COMPARATOR

ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique

Procedure: L3 LPBDrug: 0.375%ropivacaine 25 ml (Raropin)Procedure: General anesthesia with tracheal intubation

T12 combined with L3 and L4 LPB technique (TP group)

ACTIVE COMPARATOR

ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique

Procedure: L3 LPBProcedure: L4 LPBProcedure: T12 blockDrug: 0.375%ropivacaine 40 ml (Raropin)Procedure: General anesthesia with tracheal intubation

L3 LPB combined with QLB (LPQLB-SNT, PQ group)

EXPERIMENTAL

ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique

Procedure: L3 LPBProcedure: L3 QLBDrug: 0.375%ropivacaine 40 ml (Raropin)Procedure: General anesthesia with tracheal intubation

Interventions

L3 LPBPROCEDURE

ultrasound-guided L3 lumbar plexus block

L3 LPB combined with QLB (LPQLB-SNT, PQ group)L3 LPB technique (P group)T12 combined with L3 and L4 LPB technique (TP group)
L4 LPBPROCEDURE

ultrasound-guided L4 lumbar plexus block

T12 combined with L3 and L4 LPB technique (TP group)
T12 blockPROCEDURE

ultrasound-guided thoracic 12th segment nerve block

T12 combined with L3 and L4 LPB technique (TP group)
L3 QLBPROCEDURE

ultrasound-guided quadratus lumborum block at L3 level

L3 LPB combined with QLB (LPQLB-SNT, PQ group)

0.375%ropivacaine (Raropin) 25ml will be given

L3 LPB technique (P group)

0.375%ropivacaine (Raropin) 40ml will be given

L3 LPB combined with QLB (LPQLB-SNT, PQ group)T12 combined with L3 and L4 LPB technique (TP group)

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

L3 LPB combined with QLB (LPQLB-SNT, PQ group)L3 LPB technique (P group)T12 combined with L3 and L4 LPB technique (TP group)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (2)

  • Wang X, Zhang J, Xie Z, Chen Y, Yonglin-Chen, Rao Z, Zhang H. Efficacy and safety of combined lumbar plexus and quadratus lumborum block via Shamrock approach at L3 in total hip arthroplasty: a prospective randomized controlled trial. Trials. 2025 Nov 4;26(1):467. doi: 10.1186/s13063-025-09195-w.

  • Wang X, Zhang H, Chen Y, Xie Z, Chen M, Chen Y, Zhang J. The anesthetic efficacy of ultrasound-guided lumbar plexus combined with quadratus lumborum block with Shamrock approach in total hip arthroplasty: study protocol for a randomized controlled trial. Trials. 2023 Sep 18;24(1):596. doi: 10.1186/s13063-023-07619-z.

MeSH Terms

Conditions

Osteoarthritis, HipHip FracturesFemur Head Necrosis

Interventions

Anesthesia, GeneralIntubation, Intratracheal

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesOsteonecrosisBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAirway ManagementTherapeuticsIntubationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

July 9, 2020

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Data with patient identification will not be publicly accessible after the study.

Locations