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Efficacy of Local Anesthetic Through Continuous Infusion

NCT ID: NCT04173312

Last Updated: 2022-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2023-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Infusion will be the same for both groups. One will have analgesic and one will have saline.

Study Groups

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Infused analgesic

Patients will be assigned to receive local anesthetic through continuous infusion by pump.

Group Type ACTIVE_COMPARATOR

Bupivacaine infusion

Intervention Type COMBINATION_PRODUCT

Local systemic Infusion of anesthetic

Infused saline

Patients will be assigned to receive saline through continuous infusion by pump.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type COMBINATION_PRODUCT

Local systemic infusion of saline

Interventions

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Bupivacaine infusion

Local systemic Infusion of anesthetic

Intervention Type COMBINATION_PRODUCT

Saline

Local systemic infusion of saline

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

\- Patients scheduled for elective laparotomy

Exclusion Criteria

* Emergency laparotomy
* Pregnancy
* Patients on chronic pain medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascension Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Tarik Wasfie, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarik Wasfie, MD

Role: PRINCIPAL_INVESTIGATOR

Ascension Health

Locations

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Ascension Genesys Hospital

Grand Blanc, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tarik Wasfie, MD

Role: CONTACT

[email protected]
8108539900

Kimberly Barber, PhD

Role: CONTACT

[email protected]
8106067724

Facility Contacts

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Tarik Wasfie, MD

Role: primary

[email protected]
810-853-9900

Sandra Watt, RN

Role: backup

[email protected]
810-6067713

Other Identifiers

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AscensionGenesysH

Identifier Type: -

Identifier Source: org_study_id

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