Efficacy of Local Anesthetic Through Continuous Infusion

Study Overview
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Brief Summary
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Efficacy of using continuous infusion of local anesthetic for post operative pain control following laparotomy.

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.

Official Title
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Efficacy of Local Anesthetic Through Continuous Infusion Following Laparotomy Procedures.

Conditions
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Pain Control

Intervention / Treatment
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* Combination Product: Bupivacaine infusion
* Combination Product: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients scheduled for elective laparotomy Exclusion Criteria: Emergency laparotomy Pregnancy Patients on chronic pain medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anesthetic, continuous infusion, pain control