Truncal Ultrasound Guided Regional Anesthesia for Implant... | NCT04184349

NCT04184349

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Local Anesthetic (LA Group)	Active Comparator		Drug: LA group
B group	Active Comparator		Drug: B Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LA group	Drug	In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.	Local Anesthetic (LA Group)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram		From 24 hours after procedure to 48 hours after procedure
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram		up to 24 hours after procedure

Secondary Outcomes

Measure	Description	Time Frame
Pain as Measured by the Visual Analog Scale (VAS) Pain Score	VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity.	up to 1.5 hours post procedure in post anesthesia care unit (PACU)
Pain as Measured by the Visual Analog Scale (VAS) Pain Score

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Olga Pewelek, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston		Houston	Texas	77030	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
FG001	B Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

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	Dec 19, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
BG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00010 BG0019 BG00219

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000.035± 0.082 OG0010.008± 0.026

Primary

Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram

Posted

Mean

Standard Deviation

MME per kg

up to 24 hours after procedure

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants	OG000

Secondary

Pain as Measured by the Visual Analog Scale (VAS) Pain Score

VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity.

Data were not collected for this outcome measure because this assessment was not used in the PACU. The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale was used instead.

Posted

up to 1.5 hours post procedure in post anesthesia care unit (PACU)

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants	OG000

Secondary

Pain as Measured by the Visual Analog Scale (VAS) Pain Score

VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.

Data were not collected from 1 participant in the Local Anesthetic (LA Group) arm because it was not charted by bedside nurse.

Posted

Mean

Standard Deviation

score on a scale

up to 24 hours post procedure

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants	OG000

Secondary

Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale

Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment measures pain with a total score that ranges from 0 to 10; a higher score indicating greater pain.

Data were not collected from 3 participants in the Local Anesthetic (LA Group) arm because it was not charted by bedside nurse. Data were not collected from 1 participant in the B group arm because it was not charted by bedside nurse.

Posted

Mean

Standard Deviation

score on a scale

up to 6 hours post procedure in post anesthesia care unit (PACU)

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants

Secondary

Number of Patients With the Incidence of Pruritis

Posted

Count of Participants

Participants

up to 48 hours after procedure

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants	OG000

Secondary

Number of Patients With the Incidence of Nausea/Vomiting

Posted

Count of Participants

Participants

up to 48 hours after procedure

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants	OG000

Secondary

Number of Patients With Respiratory Depression

Posted

Count of Participants

Participants

up to 48 hours after procedure

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants	OG000

Secondary

Number of Patients With Local Anesthetic Toxicity

Posted

Count of Participants

Participants

up to 48 hours after procedure

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants	OG000

Secondary

Number of Patients With Incidence of Pneumothorax

Posted

Count of Participants

Participants

up to 48 hours after procedure

ID	Title	Description
OG000	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
OG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Units	Counts
Participants	OG000

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	Local Anesthetic (LA Group)	LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.	0	10	0	10	0	10
EG001	B Group	B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.	0	9	0	9	0	9

First MCP Posted Date