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Completed

NCT Number: NCT06675916

Assessment of PENG Block Analgesia Versus Intra-articular Infiltration in Hip Prosthesis Surgery

After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours.

Pain management (analgesia) after hip prosthetic surgery remains a challenge. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact.

The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits.

A new peripheral nerve block, the PENG block has shown very encouraging results on postoperative analgesia quality.

In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration during mini-invasive anterior hip prosthesis surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Médipôle Hôpital Privé

Villeurbanne, 69100, France

About this study

Each year, around140 000 patients undergo total hip arthroplasty. After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours. However, more and more patients want to no longer suffer after surgery. Indeed, if postoperative pain is moderate at rest, it is often exacerbated by movement. Severe pain occurs in 50 % of patients at rest and in 70% of patients during mobilization.

Pain management (analgesia) after hip prosthetic surgery remains a challenge for the anesthesiologist. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact. Quality analgesia is therefore essential to reduce post-operative pain and improve functional rehabilitation in patients undergoing hip surgery.

The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits: rapid and non-lasting effect of analgesia or poor targeting of all nerves of hip joint.

A new peripheral nerve block, the PENG block, identified during a recent anatomical study in 2018, has shown very encouraging results on postoperative analgesia quality on several small series of patients.

In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration and therefore reduce the intraoperative opioid consumption during mini-invasive anterior hip prosthesis surgery under general anaesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient, male or female, over 18 years old.
  • Patient scheduled for hip prosthesis placement via the anterior approach

Exclusion criteria

  • Patient with local anesthesia contraindication.
  • Patient with a high level of dependency, defined by level 1 or 2 of Iso Ressources Group (GIR).

Treatment and study plan

PENG Block with lidocaine hydrochloride

Procedure

Intervention is ultrasound-guided PENG block analgesia with lidocaine hydrochloride

Intra-articular infiltration with lidocaine hydrochloride

Procedure

Intervention is intra-articular analgesia with lidocaine hydrochloride

Primary outcomes

  1. Morphine dose

    Time frame: 1 day

    Primary outcome measure is the total morphine quantity administered intraoperatively, in milligrams

Secondary outcomes

  1. Pain level

    Time frame: Day 0, 1, 7 and 45

    Pain is assessed with Visual Analogic Scale (0 - 10 points). 0 is the lowest pain value (patient has no pain) whereas 10 is the highest pain value.

  2. Patient quality of life

    Time frame: Day 1, 7 and 45

    Quality of life is assessed with EQ-5D-5L (EUROQOL - 5 dimensions - 5 levels) questionnaire (0 - 100 points). 0 means the worst quality of life whereas 100 means the best quality of life.

  3. Hip symptoms and limitations

    Time frame: Day 45

    Hip symptoms and limitations assessment relies on HOOS questionnaire (0 - 100 points). 0 is the worst possible score whereas 100 is the best possible score (no symptoms and no limitations)

  4. Hip impact on daily life

    Time frame: Day 45

    Hip impact on daily life is assessed with OXFORD questionnaire (12 - 60 points). 12 is the best patient score (hip has no impact on patient daily life) whereas 60 is the worst patient score

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: API

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2024
Registry last updated
Jul 16, 2026

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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