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NCT Number: NCT06257160

Superiority Randomized Controlled Trial of Ultrasound-guided PENG Block Compared to Surgical Infiltration in the Analgesia of Posterior Total Hip Arthroplasty Surgery

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.

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Key information

Conditions

Hip Arthropathy Agnosia Arthritis Hip Arthrosis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Osteoarthritis, Hip Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damien JOLLY

Reims, France

About this study

The aim of this study was to compare the clinical efficacy of these two locoregional analgesia strategies in posterior total hip replacement surgery: ultrasound-guided PENG block and surgical infiltration.

The study is a superiority randomized, double-blind (patient and evaluator will be blinded to the randomization group), single-center trial.

Two groups of patients will be compared: a group of patients benefiting from the echo-guided PENG block strategy, and a group of patients benefiting from intraoperative surgical infiltration.

The type of treatment (PENG block or surgical infiltration) will be randomized. The target population concerns patients scheduled for posterior total hip replacement surgery at Reims University Hospital If the hypothesis of the superior efficacy of echo-guided block PENG is confirmed, our analgesia strategy for total hip replacement surgery will be modified, enabling us to offer the most effective locoregional analgesia technique and thus reduce the morbidity and mortality associated with morphine consumption.

This could have both a medical and an economic impact, by optimizing post-operative monitoring and convalescence for these patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Surgical infiltration

Procedure

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.

PENG Block ultrasound-guided

Procedure

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.

Primary outcomes

  1. Morphine consumption

    Time frame: At 24 hours postoperative

Secondary outcomes

  1. Pain evaluation

    Time frame: At 1 hour postoperative

    Numeric pain intensity scale

  2. Pain evaluation

    Time frame: At 2 hours postoperative

    Numeric pain intensity scale

  3. Pain evaluation

    Time frame: At 6 hours postoperative

    Numeric pain intensity scale

  4. Pain evaluation

    Time frame: At 12 hours postoperative

    Numeric pain intensity scale

  5. Pain evaluation

    Time frame: At 24 hours postoperative

    Numeric pain intensity scale

  6. Pain evaluation

    Time frame: At 36 hours postoperative

    Numeric pain intensity scale

  7. Pain evaluation

    Time frame: At 48 hours postoperative

    Numeric pain intensity scale

  8. Success or failure at first stand up test

    Time frame: At 4 hours postoperative

  9. Need for analgesia rescue technique

    Time frame: At 24 hours postoperative

  10. 10 meters walk test

    Time frame: At 24 hours postoperative

  11. Muscle strength test

    Time frame: At 24 hours postoperative

  12. Length of hospital stay

    Time frame: At the end of the stay

  13. Adverse events due to consumption of morphine

    Time frame: At 24 hours postoperative

  14. Adverse events due to PENG block ou surgical infiltration

    Time frame: At 24 hours postoperative

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: PENGORINF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2024
Registry last updated
Dec 3, 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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