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

NCT ID: NCT06675916

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-31

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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PENG block

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

Group Type: EXPERIMENTAL

PENG Block with lidocaine hydrochloride

Intervention Type: PROCEDURE

Intervention is ultrasound-guided PENG block analgesia with lidocaine hydrochloride

Intra-articular infiltration

Total hip prosthesis with intra-articular infiltration of lidocaine hydrochloride

Group Type: ACTIVE_COMPARATOR

Intra-articular infiltration with lidocaine hydrochloride

Intervention Type: PROCEDURE

Intervention is intra-articular analgesia with lidocaine hydrochloride

Interventions

PENG Block with lidocaine hydrochloride

Intervention is ultrasound-guided PENG block analgesia with lidocaine hydrochloride

Intervention Type: PROCEDURE

Intra-articular infiltration with lidocaine hydrochloride

Intervention is intra-articular analgesia with lidocaine hydrochloride

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Médipôle Hôpital Privé

Villeurbanne, , France

Countries

France

Other Identifiers

2021-A00539-32

Identifier Type: -

Identifier Source: org_study_id