Regional Anesthesia in THR - Comparing the Analgesic Effi... | NCT04574154

Studies
Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

NCT04574154

Sponsor

Papa Giovanni XXIII Hospital

Status

Completed

Last Update Posted

Dec 9, 2021Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

FIB
ESPB
spinal anesthesia

Countries

Italy

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2020Actual

Primary Completion Date

May 15, 2021Actual

Completion Date

Aug 21, 2021Actual

First Submitted Date

Jan 8, 2020

First Submission Date that Met QC Criteria

Sep 28, 2020

First Posted Date

Oct 5, 2020Actual

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

Nov 28, 2021

Last Update Posted Date

Dec 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dario Bugada, MD PhD, principal investigator, attending anesthesiologist, Papa Giovanni XXIII HospitalPrincipal Investigator

Lead Sponsor

Papa Giovanni XXIII HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FIB	Experimental	ultrasound guided Fascia Iliaca Block	Procedure: FIB Procedure: spinal anesthesia
ESPB	Experimental	ultrasound guided Erector Spinae Plane Block	Procedure: ESPB Procedure: spinal anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FIB	Procedure	FIB with ultrasound: Ropivacaine 0.5% 40 ml	FIB
ESPB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
morphine	milligrams of morphine consumed in the first postoperative day	24 hours

Secondary Outcomes

Measure	Description	Time Frame
perceived postoperative pain: Numeric Rating Scale (NRS)	11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"	24 hs
perceived postoperative pain: Numeric Rating Scale (NRS)	11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary THR
informed consent

Exclusion Criteria:

allergies to study drugs
spinal anesthesia contraindicated
kidney failure
epilepsy, psychiatric disease, neurologic deficits
revision surgery
neuropathies in the lumbar area
no informed consent
pregnancy
alcohol/opioid abuse
emergency surgery/intensive care

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aast Papa Giovanni Xxiii		Bergamo		24127	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000775	Anesthesia, Spinal

Ancestor Terms

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided