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

Not Applicable

Recruiting

• Conditions: Prospective; Randomized; Double-blind
• Interventions: Drug: Ropivacaine; Other: Physiological saline

• Registration Number: NCT06557044
• Lead Sponsor: Diakonie-Klinikum Stuttgart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-07
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum Group	Ropivacaine	20 ml ropivacaine 0.5%
Placebo Group	Physiological saline	20 ml physiological saline

Primary Outcome Measures

Name	Time	Method
Rate of postoperative opioid administration	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 Outcome Measures

Name	Time	Method
Quantity of total opioid consumption	until the evening of the second postoperative day	Assessment of total opioid consumption until second postoperative day in both arms
Intensity of postoperative pain	until the evening of the second postoperative day	Subjective perception of postoperative pain, using the numeric rating scale.
Intensity of postoperative nausea and vomiting	until the evening of the second postoperative day	Assessment of postoperative nausea/vomiting using the PONV Score
Postoperative recovery	until the evening of the second postoperative day	Assessment of postoperative recovery using the QoR15 score

Trial Locations

Locations (1)

Diakonie-Klinikum Stuttgart; 🇩🇪 Stuttgart, Baden-Württemberg, Germany