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

NCT06557044 — Not applicable, Unknown, 110 participants, Diakonie-Klinikum Stuttgart

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

Registry	NCT06557044, acronym PENG
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	110 (Estimated)
Sponsor	Diakonie-Klinikum Stuttgart (Other); collaborators: University Hospital Tuebingen
Conditions	Prospective, Randomized, Double-blind
Interventions	Ropivacaine, Physiological saline (Drug, other)
Dates	start 2024-03-07, primary completion 2025-03-01 (estimated), completion 2025-03-01 (estimated), first posted 2024-08-16, last updated 2024-08-16
Locations	1 site in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Verum Group	Experimental	Drug: Ropivacaine	20 ml ropivacaine 0.5%
Placebo Group	Placebo comparator	Other: Physiological saline	20 ml physiological saline

Ropivacaine (Drug): PENG block with ropivacaine
Physiological saline (Other): Placebo control

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Diakonie-Klinikum Stuttgart	Stuttgart, Baden-Wurttemberg	Germany	Recruiting

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