Clinical Trials Directory

Trials / Terminated

TerminatedNCT04033562

The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
2 (actual)
Sponsor
WellSpan Health · Academic / Other
Sex
Female
Age
18 Years – 100 Years
Healthy volunteers
Accepted

Summary

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

Detailed description

Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Conditions

Interventions

TypeNameDescription
DRUGLidocaine patchLidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.
DEVICEAmbu ACTion pump, 0.125% bupivacaine at 8cc/hrInfusion pump will be placed at time of Cesarean delivery for post-operative pain control.

Timeline

Start date
2020-01-15
Primary completion
2021-05-17
Completion
2021-05-17
First posted
2019-07-26
Last updated
2021-06-07

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04033562. Inclusion in this directory is not an endorsement.