Pericapsular Nerve Group Block for Elective Hip Arthroplasty

NCT ID: NCT04231123

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2022-03-15

Brief Summary

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This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.

Detailed Description

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Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty.

Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients.

The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Injected solutions will be prepared by an anesthetist not involved in the study protocol.

Study Groups

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PENG group

PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine

Group Type EXPERIMENTAL

PENG Block with local anesthetic

Intervention Type PROCEDURE

After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.

Placebo group

PENG block with 20 ml of 0,9% saline

Group Type PLACEBO_COMPARATOR

PENG Block with 0,9% saline

Intervention Type PROCEDURE

After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.

Interventions

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PENG Block with local anesthetic

After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.

Intervention Type PROCEDURE

PENG Block with 0,9% saline

After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective total hip arthroplasty
* General anesthesia
* Enhanced Recovery Program

Exclusion Criteria

* American Society of Anesthesiologists (ASA) Score \> 2
* Drug allergy
* Significant psychiatric disturbances
* Preoperative opioid use
* Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
* Body Mass Index \> 40 kg/m²
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Tivoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Van Rompaey, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Tivoli

Locations

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Chu Tivoli

La Louvière, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Nicolas Van Rompaey, MD

Role: CONTACT

+3264276111

Facility Contacts

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Nicolas Van Rompaey, M.D.

Role: primary

References

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Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

Reference Type BACKGROUND
PMID: 30063657 (View on PubMed)

Other Identifiers

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2019-001956-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P2019/482

Identifier Type: -

Identifier Source: org_study_id

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