Skip to content

Efficacy of Local Anesthetic Through Continuous Infusion

Efficacy of Local Anesthetic Through Continuous Infusion Following Laparotomy Procedures.

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04173312
Enrollment
120
Registered
2019-11-21
Start date
2021-01-04
Completion date
2023-12-31
Last updated
2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Control

Keywords

local anesthetic, continuous infusion, pain control

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.

Interventions

COMBINATION_PRODUCTBupivacaine infusion

Local systemic Infusion of anesthetic

COMBINATION_PRODUCTSaline

Local systemic infusion of saline

Sponsors

Ascension Health
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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

Intervention model description

Randomized control trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Patients scheduled for elective laparotomy

Exclusion criteria

* Emergency laparotomy * Pregnancy * Patients on chronic pain medication

Design outcomes

Primary

MeasureTime frameDescription
Self Reported Pain5 daysPatient 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.

Countries

United States

Contacts

Primary ContactTarik Wasfie, MD
twasfie@gmail.com8108539900
Backup ContactKimberly Barber, PhD
kimberly.barber@ascension.org8106067724

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026