Efficacy of Local Anesthetic Through Continuous Infusion | NCT04173312

Studies
Efficacy of Local Anesthetic Through Continuous Infusion

NCT04173312

Sponsor

Ascension Health

Status

Unknown status

Last Update Posted

Feb 23, 2022Actual

Enrollment

120Estimated

Phase

Phase 3

Conditions

Pain Control

Interventions

Bupivacaine infusion
Saline

Countries

United States

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2021Actual

Primary Completion Date

Jan 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Nov 20, 2019

First Submission Date that Met QC Criteria

Nov 20, 2019

First Posted Date

Nov 21, 2019Actual

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

Feb 22, 2022

Last Update Posted Date

Feb 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarik Wasfie, MD, Principle Investigator, Ascension HealthPrincipal Investigator

Lead Sponsor

Ascension HealthINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Efficacy of using continuous infusion of local anesthetic for post operative pain control following laparotomy.

Detailed Description

This study will evaluate the benefits of placing an analgesic pain pump in laparotomy incisions with the addition of intravenous/oral pain medications as needed versus using solely intravenous and oral pain medications as needed for post-operative pain management. The goal of this study will be to decrease the usage of narcotics in post-operative laparotomy patients by providing local incision pain relief. This will be a double blinded randomized control study with placebo with two groups of patients: One with a local anesthetic infusion pump filled with Bupivacaine, a local anesthetic, after laparotomy and the other group with an infusion pump filled with normal saline. The pain pumps will be placed in the OR. Post-operatively, all patients will have the standard pain regimen available to them during their stay. Surgeons will monitor the patient for 4 days post-operatively and the infusion pain pump will be removed on post-operative day 4. Investigator will then look back through each patient's records and gather the amount of pain medications that they requested during their stay. Both groups will then have their data collected in the same manner and placed for data analysis. - The standard pain regimen will include a morphine IV 4mg every 4 hours and Hydrocodone-acetominophen 5/325 Q6H PRN. If a patient controlled analgesia infusion pump is needed this will be considered a need for increase in pain management. Every patient will be started on this pain regimen post operatively. During their stay, If the patient requires an increase in their pain medication, the supervising attending will determine which drug will be added in improve their pain. At the end of the patients stay, the amount of narcotic usage will be compiled and turned into morphine equivalents in order to compare them with the control group.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infused analgesic	Active Comparator	Patients will be assigned to receive local anesthetic through continuous infusion by pump.	Combination Product: Bupivacaine infusion
Infused saline	Placebo Comparator	Patients will be assigned to receive saline through continuous infusion by pump.	Combination Product: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine infusion	Combination Product	Local systemic Infusion of anesthetic	Infused analgesic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self Reported Pain	Patient reported pain rating on the Visual Analog Scale (VAS) for Pain. Pain intensity is rated on a scale of 0 to 100. It is anchored by 0 for no pain and 100 for worst pain ever.	5 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients scheduled for elective laparotomy

Exclusion Criteria:

Emergency laparotomy
Pregnancy
Patients on chronic pain medication

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
Tarik Wasfie, MD	Contact	8108539900		twasfie@gmail.com
Kimberly Barber, PhD	Contact	8106067724		kimberly.barber@ascension.org

Overall Officials

Name	Affiliation	Role
Tarik Wasfie, MD	Ascension Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ascension Genesys Hospital	Recruiting	Grand Blanc	Michigan	48439	United States

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
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided