NCT05654519

Brief Summary

Adequate pain management following total hip arthroplasty (THA) is a key component for patient satisfaction and early ambulation. However, due to the complexity of the innervation of the hip joint, the most appropriate anaesthetic and analgesic technique for THA remains unclear. A femoral nerve block is commonly performed and well established but is associated with motor weakness. Recently, the pericapsular nerve group (PENG) block has been introduced as an effective choice which targets the articular branches of the hip. The quadratus lumborum block (QLB) is a relatively new regional block that has been reported to provide effective analgesia for THA. The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to QLB block in terms of efficacy of pain control and the safety profile after total hip arthroplasty under spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

December 20, 2024

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

November 30, 2022

Last Update Submit

December 17, 2024

Conditions

Keywords

Total Hip SurgeryPENG blockQLB

Outcome Measures

Primary Outcomes (2)

  • Pain scores

    Numerical Rating Scale-NRS (0 = no pain and 10 = worst imaginable painranged from 0 to 10)

    Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours

  • Opioid consumption

    Mean opioid consumption in morphine equivalents

    Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours

Secondary Outcomes (3)

  • Quadriceps muscle strength

    Postoperative 24 hours period

  • Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression

    Postoperative 24 hours period

  • Patient satisfaction

    Postoperative 24 hours period

Study Arms (2)

Group QL Block

ACTIVE COMPARATOR

A convex transducer will be placed in the transverse plane on the flank cranial to the iliac crest to visualise the transverse process of the 4th lumbar vertebra, erector spina, quadratus lumborum and psoas muscles as a 'Shamrock sign'. The needle will inserted in to the fascial plane between the quadratus lumborum and psoas muscles and 30 ml bupivacaine 0.25% will be administered.

Drug: PENG/LFCN and QL Blocks

Group PENG+LFCN Block

ACTIVE COMPARATOR

A linear probe will be placed on the anterior inferior iliac crest in the transverse plane while the patient is in the supine position. After rotating 45 degrees, the pubic ramus, femoral artery and psoas muscle will be visualized. Puncture will be performed in a lateromedial direction until the needle tip reached the plane between the iliopsoas tendon and the iliopubic eminence After a negative aspiration test, 25 ml bupivacaine 0.25% will be injected. Then, the lateral femoral cutaneous nerve (LFCN) block was performed using linear US probe (10-18 MHz).The LFCN will be localized, infero-medially to the antero-superior iliac spine, laterally to the sartorius muscle and 5 ml of bupivacaine 0.25% will be carefully injected.

Drug: PENG/LFCN and QL Blocks

Interventions

Bupivacaine 0.25% injection

Group PENG+LFCN BlockGroup QL Block

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physical status according to American Society of Anesthesiologists (ASA ) I-III

You may not qualify if:

  • Younger than 40 years old and older than 85
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • Infection of the skin at the site of the needle puncture,
  • Patients who do not accept the procedure
  • History of bleeding diathesis
  • ASA IV,
  • Chronic gabapentin/pregabalin,opioid use
  • Hepatic or renal insufficiency
  • Previous operation on the same hip
  • BMI \>40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alper KILICASLAN

Konya, Turkey (Türkiye)

Location

Related Publications (2)

  • Hussain N, Brull R, Speer J, Hu LQ, Sawyer T, McCartney CJL, Abdallah FW. Analgesic benefits of the quadratus lumborum block in total hip arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2022 Oct;77(10):1152-1162. doi: 10.1111/anae.15823. Epub 2022 Aug 10.

    PMID: 35947882BACKGROUND
  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

    PMID: 30063657BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient, and the outcomes assessor who performs postoperative pain evaluation will not know the group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 16, 2022

Study Start

January 1, 2022

Primary Completion

April 10, 2023

Study Completion

April 21, 2023

Last Updated

December 20, 2024

Record last verified: 2023-04

Locations