NCT06257160

Brief Summary

Pain after total hip replacement (THR) surgery is severe. The target population is elderly and comorbid. Level III analgesics are responsible for significant side effects in this population. Locoregional analgesia, by reducing the consumption of painkillers, is an effective way of reducing morphine or morphine agonist consumption in this surgery. Furthermore, these techniques fit in perfectly with the objectives of accelerated rehabilitation after surgery. Surgical infiltration is a frequently used and effective analgesic technique. PENG block is a new locoregional anesthesia technique which initial results show promising analgesic efficacy and the absence of loss of strength through motor block. In February 2022, we carried out a survey of national anesthetic practices in posterior hip arthroplasty, with the help of the SFAR (Société Française d'Anesthésie-Réanimation). It shows that, despite the lack of plentiful literature on the subject, the PENG block is currently the most frequently performed pre-operative block in hip arthroplasty (PENG block in 39.5% of cases, femoral block in 13% of cases). The survey also shows that in 41.5% of cases, no block is performed, and only intraoperative surgical infiltration is carried out. PENG block and surgical infiltration are therefore the two analgesic techniques most frequently used in France today. It is for these reasons that we feel it is essential to carry out a study comparing these two techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 22, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2025

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

February 6, 2024

Last Update Submit

November 25, 2025

Conditions

Keywords

AnalgesiaHipArthroplastyPENGlocoregional anesthesiainfiltration

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    At 24 hours postoperative

Secondary Outcomes (14)

  • Pain evaluation

    At 1 hour postoperative

  • Pain evaluation

    At 2 hours postoperative

  • Pain evaluation

    At 6 hours postoperative

  • Pain evaluation

    At 12 hours postoperative

  • Pain evaluation

    At 24 hours postoperative

  • +9 more secondary outcomes

Study Arms (2)

Surgical infiltration

ACTIVE COMPARATOR
Procedure: Surgical infiltration

PENG Block ultrasound-guided

EXPERIMENTAL
Procedure: PENG Block ultrasound-guided

Interventions

During surgery, local anesthetics are injected as follow: in the deep plane and in the subcutaneous territory. Infiltration of the deep plane corresponds to pericotyloid injection, with particular attention to the posterior subcapsular area, the obturator foramen and the psoas muscle. Infiltration of the muscular planes is added, with infiltration of the gluteal and pelvitrochanteric muscles.

Surgical infiltration

We perform the femoral block under ultrasound after anesthesia (general or rachianesthesia). The PENG block is a peripheral diffusion nerve block that specifically targets the articular divisions of the femoral, obturator and accessory obturator nerves. The femoral nerve innervates the four parts of the joint capsule, with inconsistency in the anterior inferomedial part of the capsule. The obturator nerve innervates the inferior part of the anterior face of the capsule. The accessory obturator nerve innervates the medial half of the hip joint capsule in over 50% of cases.

PENG Block ultrasound-guided

Eligibility Criteria

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

You may qualify if:

  • Patients eligible for posterior total hip replacement surgery at Reims University Hospital
  • Patients agreeing to take part in the research and having signed the informed consent form
  • Patients of full age
  • Patients affiliated to a social security scheme

You may not qualify if:

  • Minor patients
  • Patients protected by law
  • Pregnant and breast-feeding women
  • Patients with allergy to local anesthetics
  • Patients with neuropathy
  • Patients with an ASA score greater than or equal to 4
  • Patients undergoing revision surgery on a total hip prosthesis
  • Patients undergoing anterior total hip replacement surgery
  • Patients suffering from a femur fracture
  • Patients with a contraindication to Peng block.
  • Patients refusing one of the proposed techniques.
  • Persons deprived of their liberty by judicial or administrative decision.
  • Persons under psychiatric care
  • Persons unable to express their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Osteoarthritis, HipAgnosia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 13, 2024

Study Start

May 22, 2024

Primary Completion

September 18, 2025

Study Completion

September 18, 2025

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations