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

NCT06675916 | Completed

• 1 other identifier: 2021-A00539-32
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine dose

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

  1 day

Secondary Outcomes (4)

• Pain level

  Day 0, 1, 7 and 45

• Patient quality of life

  Day 1, 7 and 45

• Hip symptoms and limitations

  Day 45

• Hip impact on daily life

  Day 45

Study Arms (2)

PENG block

EXPERIMENTAL

Total hip prosthesis with infiltration of lidocaine hydrochloride by ultrasound-guided PENG block

Procedure: PENG Block with lidocaine hydrochloride

Intra-articular infiltration

ACTIVE COMPARATOR

Total hip prosthesis with intra-articular infiltration of lidocaine hydrochloride

Procedure: Intra-articular infiltration with lidocaine hydrochloride

Interventions

PENG Block with lidocaine hydrochloride PROCEDURE

Intervention is ultrasound-guided PENG block analgesia with lidocaine hydrochloride

PENG block

Intra-articular infiltration with lidocaine hydrochloride PROCEDURE

Intervention is intra-articular analgesia with lidocaine hydrochloride

Intra-articular infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Médipôle Hôpital Privé

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: November 5, 2024
• Study Start: March 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)