drugset / Trial / NCT03383588

Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section

NCT03383588

Phase 2 Terminated 26 enrolled Montefiore Medical Center
RandomizedParallel-groupTriple-blindSupportive care

Summary

The purpose of this study is to determine if giving an injection of numbing medication at the incision at the end of cesarean will help control pain AFTER cesarean delivery. This study seeks to assess pain relief with incisional infiltration of local anesthetic during cesareans performed under spinal anesthesia also using intrathecal opioids. Participants will receive the usual regimen of pain medication in spinal anesthesia. At the end of the cesarean delivery, while the participants are still under the spinal medication, participants will receive an injection, at the incision, either numbing medication (with or without epinephrine) or sterile saline. After the cesarean delivery, participants will receive, by mouth, commonly prescribed pain medications - these medications are oxycodone (an opioid/ narcotic), acetaminophen (or more commonly known as Tylenol), and ibuprofen.

Timeline

Start
2018-07-19
Primary completion
2018-08-17
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.25 % Subcutaneous
Comparator Bupivacaine Other / unclassified 0.75 % Subcutaneous
Comparator Epinephrine Other / unclassified Subcutaneous
Comparator Fentanyl Other / unclassified 10 ug Intrathecal
Comparator Morphine Other / unclassified 150 ug Intrathecal