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Clinical Trials/NCT06557044
NCT06557044
Recruiting
Not Applicable

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

Diakonie-Klinikum Stuttgart1 site in 1 country110 target enrollmentMarch 7, 2024

Overview

Phase
Not Applicable
Intervention
Ropivacaine
Conditions
Prospective
Sponsor
Diakonie-Klinikum Stuttgart
Enrollment
110
Locations
1
Primary Endpoint
Rate of postoperative opioid administration
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2024
End Date
March 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Diakonie-Klinikum Stuttgart
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Rainer Meierhernich

Principal Investigator

Diakonie-Klinikum Stuttgart

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

Arms & Interventions

Verum Group

20 ml ropivacaine 0.5%

Intervention: Ropivacaine

Placebo Group

20 ml physiological saline

Intervention: Physiological saline

Outcomes

Primary Outcomes

Rate of postoperative opioid administration

Time Frame: 60 minutes after arrival in the recovery room

The primary objective is to investigate the influence of the PENG block on the need for postoperative ntravenously opioid administration within the first hour in the recovery room.

Secondary Outcomes

  • Quantity of total opioid consumption(until the evening of the second postoperative day)
  • Intensity of postoperative pain(until the evening of the second postoperative day)
  • Intensity of postoperative nausea and vomiting(until the evening of the second postoperative day)
  • Postoperative recovery(until the evening of the second postoperative day)

Study Sites (1)

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