The Analgesic Efficacy of Pericapsular Nerve Group (PENG)... | NCT06557044

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

NCT06557044

Sponsor

Diakonie-Klinikum Stuttgart

Status

Recruiting

Last Update Posted

Aug 16, 2024Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Prospective
Randomized
Double-blind

Interventions

Ropivacaine
Physiological saline

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2024Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Aug 8, 2024

First Submission Date that Met QC Criteria

Aug 13, 2024

First Posted Date

Aug 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2024

Last Update Posted Date

Aug 16, 2024Actual

Name	Class
University Hospital Tuebingen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Verum Group	Experimental	20 ml ropivacaine 0.5%	Drug: Ropivacaine
Placebo Group	Placebo Comparator	20 ml physiological saline	Other: Physiological saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug	PENG block with ropivacaine	Verum Group
Physiological saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Quantity of total opioid consumption	Assessment of total opioid consumption until second postoperative day in both arms	until the evening of the second postoperative day
Intensity of postoperative pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rainer Meierhenrich, Prof. Dr.	Contact	00497119912290		meierhenrich@diak-stuttgart.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diakonie-Klinikum Stuttgart	Recruiting	Stuttgart	Baden-Wurttemberg	70176	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

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