Periarticular Injection Versus Peripheral Nerve Block in... | NCT03977454

Periarticular Injection Versus Peripheral Nerve Block in... | NCT03977454 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1 patients will receive nerve block per standard of care	Experimental	Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI.	Procedure: Nerve Block Drug: Ropivacaine
Group 2 will NOT receive any nerve blocks.	Active Comparator	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon.	Procedure: Periarticular Injection (PAI) Drug: Ropivacaine Drug: Dex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nerve Block	Procedure	Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily Opioid Consumption	Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.	Up to 72 hours

Secondary Outcomes

Measure	Description	Time Frame
Change in Pain Intensity While in Hospital	Pain intensity will be assessed using a pain inventory modified from Brief Pain Inventory (BPI). The BPI has a range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Outcome measure was updated at the time of results entry.	Up to 2 days

Contacts/Locations Module

Name	Affiliation	Role
Jinlei Li, MD PhD FASA	Yale University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yale-New Haven Hospital St Raphael		New Haven	Connecticut	06511	United States

Arm/Group Information

ID	Title	Description
FG000	Group Will NOT Receive Any Nerve Blocks.	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine Dex: 10 mg DEX/ 80 mg MPA
FG001	Group Will Receive Nerve Block Per Standard of Care	Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI. Nerve Block: Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00097 subjects FG00195 subjects
COMPLETED		FG00095 subjects FG00193 subjects
NOT COMPLETED		FG0002 subjects FG0012 subjects

Type	Comment	Reasons
immediate postoperative revision		FG0002 subjects FG0012 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Group Will NOT Receive Any Nerve Blocks.	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine Dex: 10 mg DEX/ 80 mg MPA

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Daily Opioid Consumption

Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.

Final analysis population (completed from Participant Flow)

Posted

Mean

Standard Deviation

milligram

Up to 72 hours

ID	Title	Description
OG000	Group Will NOT Receive Any Nerve Blocks.	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine Dex: 10 mg DEX/ 80 mg MPA

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group Will NOT Receive Any Nerve Blocks.	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine Dex: 10 mg DEX/ 80 mg MPA

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Jinlei Li, MD, PhD	Yale School of Medicine: Anesthesiology	(203) 785-2802		jinlei.li@yale.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 17, 2021	Aug 26, 2022	Prot_SAP_000.pdf

Intervention Browse Module

ID	Term
D009407	Nerve Block
D000077212	Ropivacaine

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia
D003714	Denervation

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0012 BG0026
Not Hispanic or Latino	BG00089 BG00191 BG002180
Unknown or Not Reported	BG0002 BG0010 BG0022

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG00013 BG00111 BG00224
White	BG00077 BG00178 BG002155
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0005 BG0014 BG0029

Title

Denominators

Categories

12 hours Post Op

Title	Measurements
	OG00029.3± 24.0 OG00130.8± 22.7

24 hours Post Op

Title	Measurements
	OG00049.6± 36.8 OG00151.8± 37.5

48 Hours Post Op

Title	Measurements
	OG00062.1± 47.7 OG00167.7± 52.4

72 Hours Post Op

Title	Measurements
	OG00068.6± 58.5 OG00171.4± 55.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The primary endpoint was a comparison between groups at 24 hours.	t-test, 2 sided		0.69		Mean Difference (Net)	1.2			2-Sided								Superiority

Secondary

Change in Pain Intensity While in Hospital

Pain intensity will be assessed using a pain inventory modified from Brief Pain Inventory (BPI). The BPI has a range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Outcome measure was updated at the time of results entry.

Final analysis population (completed from Participant Flow)

Posted

Mean

Standard Deviation

units on a scale

Up to 2 days

ID	Title	Description
OG000	Group Will NOT Receive Any Nerve Blocks.	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine Dex: 10 mg DEX/ 80 mg MPA
OG001	Group Will Receive Nerve Block Per Standard of Care	Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI. Nerve Block: Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine

Units	Counts
Participants	OG00095 OG00193

Title

Denominators

Categories

Pre Operation

Title	Measurements
	OG0004.9± 2.4 OG0015.0± 2.1

Post Operation Day 1

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Scores were compared at 2 days post operation.	t-test, 2 sided		0.92		Mean Difference (Net)	0.1			2-Sided								Superiority

Secondary

Length of Stay

The patient's post surgical length of stay in the hospital will be compared between treatment groups. Length of stay is presented as average total hours in hospital.

Final analysis population (completed from Participant Flow)

Posted

Mean

Standard Deviation

hours

Up to 5 days

ID	Title	Description
OG000	Group Will NOT Receive Any Nerve Blocks.	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine Dex: 10 mg DEX/ 80 mg MPA
OG001	Group Will Receive Nerve Block Per Standard of Care	Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI. Nerve Block: Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine

Units	Counts
Participants	OG00095 OG00193

Title

Denominators

Categories

Title	Measurements
	OG00047.2± 24.8 OG00146.7± 25.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.91		Mean Difference (Net)	0.5			2-Sided								Superiority

Secondary

Harris Hip Score

The Harris Hip Score (HHS) assesses post operative conditions following hip surgery. The HHS uses a 100 point score wherethe scores are interpreted as follows: < 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent.

This measure was not used but the Brief Pain Inventory: Interference scale was used instead.

Posted

2 weeks post operation

ID	Title	Description
OG000	Group Will NOT Receive Any Nerve Blocks.	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine Dex: 10 mg DEX/ 80 mg MPA
OG001	Group Will Receive Nerve Block Per Standard of Care	Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI. Nerve Block: Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine

Units	Counts
Participants	OG0000 OG0010

Secondary

Brief Pain Inventory: Interference

The Brief Pain Inventory: Interference (BPI:I) was used in place of the Harris Hip Score (HHS) to assess post operative conditions following hip surgery. The BPI:I uses a 10 point score where the normal range of scores is: 0 no interference - 10 complete interference.

Final analysis population (completed from Participant Flow)

Posted

Mean

Standard Deviation

units on a scale

2 weeks post operation

ID	Title	Description
OG000	Group Will NOT Receive Any Nerve Blocks.	Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Periarticular Injection (PAI): Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine Dex: 10 mg DEX/ 80 mg MPA
OG001	Group Will Receive Nerve Block Per Standard of Care	Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI. Nerve Block: Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Ropivacaine: 60 ml 0.2% ropivacaine

Units	Counts
Participants	OG00095 OG00193

Title

Denominators

Categories

Pre Operation

Title	Measurements
	OG0006.2± 2.5 OG0016.3± 2.2

2 Weeks Post Operation

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Scores were compared at 2 weeks.	t-test, 2 sided		0.85		Mean Difference (Net)	0.0			2-Sided								Superiority