Menu
Recruiting NCT06557044

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

No phase Interventional Prospective Randomized Double-blind

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropivacaine, Physiological saline.
Who it may be relevant to
Registry conditions: Prospective, Randomized, Double-blind. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty: a Prospective, Double-blinded, Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Ropivacaine
    PENG block with ropivacaine
  • Other Physiological saline
    Placebo control

Primary outcome measures

  • Rate of postoperative opioid administration [Time frame: 60 minutes after arrival in the recovery room]
Secondary outcome measures (4)
  • Quantity of total opioid consumption [Time frame: until the evening of the second postoperative day]
  • Intensity of postoperative pain [Time frame: until the evening of the second postoperative day]
  • Intensity of postoperative nausea and vomiting [Time frame: until the evening of the second postoperative day]
  • Postoperative recovery [Time frame: until the evening of the second postoperative day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Diakonie-Klinikum Stuttgart — Stuttgart

Identifiers

NCT: NCT06557044 · Diak 001/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗