Efficacy of Local Anesthetic Through Continuous Infusion

Sponsor

Ascension Genesys Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04173312

Collaborator

(none)

120

Enrollment

Location

Arms

34.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain Control	Combination Product: Bupivacaine infusion Combination Product: Saline	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized control trialRandomized control trial

Masking:

Double (Participant, Investigator)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

Efficacy of Local Anesthetic Through Continuous Infusion Following Laparotomy Procedures.

Actual Study Start Date :

Jan 4, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Infused analgesic Patients will be assigned to receive local anesthetic through continuous infusion by pump.	Combination Product: Bupivacaine infusion Local systemic Infusion of anesthetic
Placebo Comparator: Infused saline Patients will be assigned to receive saline through continuous infusion by pump.	Combination Product: Saline Local systemic infusion of saline

Arm

Intervention/Treatment

Active Comparator: Infused analgesic

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

Combination Product: Bupivacaine infusion

Local systemic Infusion of anesthetic

Placebo Comparator: Infused saline

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

Combination Product: Saline

Local systemic infusion of saline

Outcome Measures

Primary Outcome Measures

Self Reported Pain [5 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients scheduled for elective laparotomy

Exclusion Criteria:

Emergency laparotomy
Pregnancy
Patients on chronic pain medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ascension Genesys Hospital	Grand Blanc	Michigan	United States	48439

Sponsors and Collaborators

Ascension Genesys Hospital

Investigators

Principal Investigator: Tarik Wasfie, MD, Ascension Genesys Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tarik Wasfie, MD, Principle Investigator, Ascension Genesys Hospital

ClinicalTrials.gov Identifier:

NCT04173312

Other Study ID Numbers:

AscensionGenesysH

First Posted:

Nov 21, 2019

Last Update Posted:

Feb 23, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Tarik Wasfie, MD, Principle Investigator, Ascension Genesys Hospital

local anesthetic

continuous infusion

pain control

Additional relevant MeSH terms:

Bupivacaine

Study Results

No Results Posted as of Feb 23, 2022