NCT04173312

Efficacy of Local Anesthetic Through Continuous Infusion

Efficacy of Local Anesthetic Through Continuous Infusion Following Laparotomy Procedures.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ascension Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain Control

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Bupivacaine infusion	Local systemic Infusion of anesthetic
COMBINATION_PRODUCT	Saline	Local systemic infusion of saline

Timeline

• Start date: 2021-01-04
• Primary completion: 2023-01-01
• Completion: 2023-12-01
• First posted: 2019-11-21
• Last updated: 2022-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study