Efficacy of Local Anesthetic Through Continuous Infusion
1 other identifier
interventional
120
1 country
1
Brief Summary
Efficacy of using continuous infusion of local anesthetic for post operative pain control following laparotomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2021
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 21, 2019
CompletedStudy Start
First participant enrolled
January 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 23, 2022
February 1, 2022
2 years
November 20, 2019
February 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Infused analgesic
ACTIVE COMPARATORPatients will be assigned to receive local anesthetic through continuous infusion by pump.
Infused saline
PLACEBO COMPARATORPatients will be assigned to receive saline through continuous infusion by pump.
Interventions
Eligibility Criteria
You may qualify if:
- \- Patients scheduled for elective laparotomy
You may not qualify if:
- Emergency laparotomy
- Pregnancy
- Patients on chronic pain medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ascension Healthlead
Study Sites (1)
Ascension Genesys Hospital
Grand Blanc, Michigan, 48439, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tarik Wasfie, MD
Ascension Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Infusion will be the same for both groups. One will have analgesic and one will have saline.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 20, 2019
First Posted
November 21, 2019
Study Start
January 4, 2021
Primary Completion
January 1, 2023
Study Completion
December 1, 2023
Last Updated
February 23, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share