The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty:

NCT ID: NCT06557044

Last Updated: 2024-08-16

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

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-07

Study Completion Date

2025-03-31

Brief Summary

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The aim of this study is to investigate the analgesic efficacy of the pericapsular nerve group (PENG) block during the implantation of hip endoprostheses. The study is designed as a prospective randomized double-blind study and the study participants were randomized into 2 arms and either 20 ml ropivacaine 0.5% (verum group) or 20 ml physiological saline solution (placebo group) will be applied.

Detailed Description

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Conditions

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Prospective Randomized Double-blind

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Verum Group

20 ml ropivacaine 0.5%

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

PENG block with ropivacaine

Placebo Group

20 ml physiological saline

Group Type PLACEBO_COMPARATOR

Physiological saline

Intervention Type OTHER

Placebo control

Interventions

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Ropivacaine

PENG block with ropivacaine

Intervention Type DRUG

Physiological saline

Placebo control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* planned cementless hip TEP operation for primary coxarthrosis via minimally invasive anterolateral approach using the identical implant system (Taperloc stem, Plamafit cup)
* Patient capable of giving consent
* Informed consent has been obtained
* age \> 18 years

Exclusion Criteria

* Refusal to participate in the study
* Regular use of opioids
* Known chronic pain symptoms
* Infections in the area of the puncture site
* Presence of a contraindication to ropivacaine
* Presence of a contraindication to metamizole
* Presence of a contraindication to postoperative analgesia with diclofenac
* Secondary forms of osteoarthritis with deformities (i.e. high-grade dysplasia, secondary conditions after trauma, secondary conditions after childtrauma, secondary conditions after childhood hip joint diseases
* Spinopelvic dysbalance, spinal canal stenosis
* Previous operations on the hip/pelvis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Diakonie-Klinikum Stuttgart

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Rainer Meierhernich

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diakonie-Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Rainer Meierhenrich, Prof. Dr.

Role: CONTACT

00497119912290

Facility Contacts

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Rainer Meierhenrich, Prof. Dr.

Role: primary

00497119912290

Other Identifiers

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Diak 001/2024

Identifier Type: -

Identifier Source: org_study_id

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