Brief 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.
Brief Title
Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section
Detailed Description
The study assesses addition of subcutaneous bupivacaine with and without epinephrine to the standard intrathecal morphine/fentanyl combination given during spinal anesthesia during elective cesarean delivery on postoperative pain control as measured by postoperative usage of oral opioids and a postoperative pain assessment scale. Comparing post-op pain scores and oxycodone usage in patients who receive just intrathecal morphine to patients who receive intrathecal morphine plus subcutaneous bupivacaine .25%, to patients who receive bupivacaine .25% with epinephrine 1:200,000.
After cesarean delivery, all groups will actively control the use of post-operative pain medication by indicating to the care nurse whether or not pain medication is desired. Pain control for all groups will be the standard pain treatment: ibuprofen for mild to moderate pain and percocet (oxycodone) for severe pain.
The U.S. Food and Drug Administration (FDA) has approved bupivicaine as an anesthetic and for pain but the FDA has not approved bupivicaine to be given specifically for postoperative cesarean pain. Acetaminophen, oxycodone and ibuprofen are being used as part of routine clinical care for pain control after cesarean. Fentanyl and duramorph are being used in spinal anesthesia and are FDA approved for regional anesthesia and used for this purpose in routine clinical care.
After cesarean delivery, all groups will actively control the use of post-operative pain medication by indicating to the care nurse whether or not pain medication is desired. Pain control for all groups will be the standard pain treatment: ibuprofen for mild to moderate pain and percocet (oxycodone) for severe pain.
The U.S. Food and Drug Administration (FDA) has approved bupivicaine as an anesthetic and for pain but the FDA has not approved bupivicaine to be given specifically for postoperative cesarean pain. Acetaminophen, oxycodone and ibuprofen are being used as part of routine clinical care for pain control after cesarean. Fentanyl and duramorph are being used in spinal anesthesia and are FDA approved for regional anesthesia and used for this purpose in routine clinical care.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pain, Referred
Eligibility Criteria
Inclusion criteria:
* elective cesarean delivery
* planned spinal anesthesia
Exclusion criteria:
* 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
* elective cesarean delivery
* planned spinal anesthesia
Exclusion criteria:
* 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
Inclusion Criteria
Inclusion criteria:
* elective cesarean delivery
* planned spinal anesthesia
* elective cesarean delivery
* planned spinal anesthesia
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
40 Years
Minimum Age
17 Years
NCT Id
NCT03383588
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-8094
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Efficacy of Subcutaneous Infiltration With Local Anesthetic During Elective Cesarean Delivery for Postoperative Pain Control: a Randomized Controlled Trial
Primary Outcomes
Outcome Description
Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record
Outcome Measure
Amount of Supplemental Oxycodone Used
Outcome Time Frame
4-24 hours post operative
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
40
Minimum Age Number (converted to Years and rounded down)
17
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jeffrey Bernstein
Investigator Email
jbernste@montefiore.org
Investigator Phone