Pain Control in Colorectal Surgery: Liposomal Bupivacaine... | NCT04005859

NCT04005859

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CONTROL: IV Lido	Active Comparator	CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)	Drug: IV Lidocaine
EXPERIMENTAL: Exparel	Experimental	EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)	Drug: Exparel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exparel	Drug	2. Liposomal bupivacaine TAP block (experimental arm) Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations. Adhesive tapes will be applied at the level of the TAP block puncture sites.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Verbal Pain Scale (VRS) - 4 Week Post-op	Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.	Single VRS assessed at 4-week post-op visit (or phone call)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Kevin Kasten, MD	Wake Forest University Health Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Atrium Health - Carolinas Medical Center		Charlotte	North Carolina	28204	United States

Arm/Group Information

ID	Title	Description
FG000	CONTROL: IV Lido	CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido) IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
FG001	EXPERIMENTAL: Exparel	EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel) Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35 Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations. Adhesive tapes will be applied at the level of the TAP block puncture sites.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	CONTROL: IV Lido	CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido) IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.

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

Verbal Pain Scale (VRS) - 4 Week Post-op

Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.

Posted

Mean

Standard Deviation

score on a scale

Single VRS assessed at 4-week post-op visit (or phone call)

ID	Title	Description
OG000	CONTROL: IV Lido	CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido) IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.

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	CONTROL: IV Lido	CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido) IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Kevin Kasten	Atrium Health	704-355-1813		kevin.kasten@atriumhealth.org

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	Feb 7, 2018	Sep 24, 2021	Prot_SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Jun 6, 2018	Aug 5, 2022	ICF_002.pdf

Intervention Browse Module

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814