Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03383588
Status:
TERMINATED
Last Update Posted:
2020-01-13
First Post:
2017-12-14
Brief Title:
Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Efficacy of Subcutaneous Infiltration With Local Anesthetic During Elective Cesarean Delivery for Postoperative Pain Control a Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study was published during initial recruitment that showed no difference
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The study assesses addition of subcutaneous bupivacaine with and without epinephrine to the standard intrathecal morphinefentanyl 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 1200000
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 US 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 US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None