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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pain, Referred

In brief

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.

Key facts

Study ID

NCT03383588

Run by

Montefiore Medical Center

People needed

26

Starts

2018-07-19

Expected to finish

2018-12-31

Last updated by the study team

2020-01-13

Who can join

Age: 17 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• elective cesarean delivery
• planned spinal anesthesia

You may not qualify if…

• Non-English speaking
• Urgent or emergent cesarean delivery
• Active labor [defined as: >4cm cervical dilation or regular contractions noted on tocometer (>2 contractions in a 10 minute period for 30 consecutive minutes)]
• Chronic antepartum opioid use
• History of substance abuse (alcohol or drug)
• Current tobacco use
• Chronic steroid use

Where it is running

• Albert Einstein College of Medicine/ Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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