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NCT Number: NCT06557044

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonie-Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70176, Germany

Location status: Recruiting

Location contact

Rainer Meierhenrich, Prof. Dr.

CONTACT

[email protected]

00497119912290

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

PENG block with ropivacaine

Physiological Saline

Other

Placebo control

Primary outcomes

  1. 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

  1. Quantity of total opioid consumption

    Time frame: until the evening of the second postoperative day

    Assessment of total opioid consumption until second postoperative day in both arms

  2. Intensity of postoperative pain

    Time frame: until the evening of the second postoperative day

    Subjective perception of postoperative pain, using the numeric rating scale.

  3. Intensity of postoperative nausea and vomiting

    Time frame: until the evening of the second postoperative day

    Assessment of postoperative nausea/vomiting using the PONV Score

  4. Postoperative recovery

    Time frame: until the evening of the second postoperative day

    Assessment of postoperative recovery using the QoR15 score

Study contacts

Contact information is provided by the study sponsor or research team.

Rainer Meierhenrich, Prof. Dr.

CONTACT

[email protected]

00497119912290

Sponsors and collaborators

Lead sponsor

Diakonie-Klinikum Stuttgart

Other

Collaborators

  • University Hospital Tuebingen

Registry information

Official study title

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

Acronym: PENG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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