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

August 13, 2024 updated by: Prof. Dr. Rainer Meierhernich, Diakonie-Klinikum Stuttgart

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany, 70176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Verum Group
20 ml ropivacaine 0.5%
Drug: Ropivacaine
PENG block with ropivacaine
Placebo Comparator: Placebo Group
20 ml physiological saline
Other: Physiological saline
Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes after arrival in the recovery room

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
until the evening of the second postoperative day
Intensity of postoperative pain
Time Frame: until the evening of the second postoperative day
Subjective perception of postoperative pain, using the numeric rating scale.
until the evening of the second postoperative day
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
until the evening of the second postoperative day
Postoperative recovery
Time Frame: until the evening of the second postoperative day
Assessment of postoperative recovery using the QoR15 score
until the evening of the second postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diakonie-Klinikum Stuttgart

Collaborators

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diak 001/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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