Efficacy of Local Anesthetic Through Continuous Infusion

Phase 3

• Conditions: Pain Control
• Interventions: Combination Product: Bupivacaine infusion; Combination Product: Saline

• Registration Number: NCT04173312
• Lead Sponsor: Ascension Health

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.

Study Timeline

• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Study Start: 2021-01-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-23
• Primary Completion: 2023-01
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients scheduled for elective laparotomy

Exclusion Criteria

• Emergency laparotomy
• Pregnancy
• Patients on chronic pain medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infused analgesic	Bupivacaine infusion	Patients will be assigned to receive local anesthetic through continuous infusion by pump.
Infused saline	Saline	Patients will be assigned to receive saline through continuous infusion by pump.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ascension Genesys Hospital; 🇺🇸 Grand Blanc, Michigan, United States