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

NCT06557044 | Recruiting

• 1 other identifier: Diak 001/2024
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Prospective; Randomized; Double-blind

Keywords

Pericapsular Nerve Group Block; hip endoprostheses

Outcome Measures

Primary Outcomes (1)

• Rate of postoperative opioid administration

  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 Outcomes (4)

• 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 Arms (2)

Verum Group

EXPERIMENTAL

20 ml ropivacaine 0.5%

Drug: Ropivacaine

Placebo Group

PLACEBO COMPARATOR

20 ml physiological saline

Other: Physiological saline

Interventions

Ropivacaine DRUG

PENG block with ropivacaine

Verum Group

Physiological saline OTHER

Placebo control

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: collaborator
• Diakonie-Klinikum Stuttgart: lead

Study Sites (1)

Diakonie-Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70176, Germany

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Rainer Meierhenrich, Prof. Dr.

CONTACT

00497119912290; meierhenrich@diak-stuttgart.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 16, 2024
• Study Start: March 7, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

DE (1)