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

Not Applicable

Completed

• Conditions: Analgesia

• Registration Number: NCT06675916
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

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 Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Study First Submitted: 2024-06-03
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morphine dose	1 day	Primary outcome measure is the total morphine quantity administered intraoperatively, in milligrams

Secondary Outcome Measures

Name	Time	Method
Patient quality of life	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.
Pain level	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.
Hip symptoms and limitations	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)
Hip impact on daily life	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

Trial Locations

Locations (1)

Médipôle Hôpital Privé; 🇫🇷 Villeurbanne, France