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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Procedure: PENG Block with lidocaine hydrochloride; Procedure: Intra-articular infiltration with lidocaine hydrochloride

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Médipôle Hôpital Privé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG block; Total hip prosthesis with infiltration of lidocaine hydrochloride by ultrasound-guided PENG block	Procedure: PENG Block with lidocaine hydrochloride; Intervention is ultrasound-guided PENG block analgesia with lidocaine hydrochloride
Active Comparator: Intra-articular infiltration; Total hip prosthesis with intra-articular infiltration of lidocaine hydrochloride	Procedure: Intra-articular infiltration with lidocaine hydrochloride; Intervention is intra-articular analgesia with lidocaine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine dose	Primary outcome measure is the total morphine quantity administered intraoperatively, in milligrams	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	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.	Day 0, 1, 7 and 45
Patient quality of life	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.	Day 1, 7 and 45
Hip symptoms and limitations	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)	Day 45
Hip impact on daily life	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	Day 45

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: 2021-A00539-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No