TerminatedPhase 4

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

Stopped: limited enrollment and unable to enroll subjects to reach statistical significance

United States2 participantsStarted 2020-01-15

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnancy * undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery * Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT) Exclusion Criteria: * Patients with a history of clinically significant cardiovascular, hepatic, or renal disease * Non-English speaking * Allergy to bupivacaine, lidocaine, zinc, silver or menthol * Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery * History of glucose-6-phosphate deficiency * Use of anti-arrhythmic drugs such as tocainide or mexiletine

What they're measuring

Pain scores

Timeframe: post-operative until 60 hours postpartum

Trial details

NCT IDNCT04033562

SponsorWellSpan Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-17

View on ClinicalTrials.gov More Opioid-use Disorder trials