Ignite Creation Date:
2024-05-05 @ 11:35 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01362998
Status:
TERMINATED
Last Update Posted:
2022-11-14
First Post:
2011-05-27
Brief Title:
Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section
Sponsor:
Goodman Evan MD
Organization:
Goodman Evan MD
Study Overview
Official Title:
A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of time and help to continue the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For post-Cesarean analgesia the investigators will compare the efficacy of single-shot epidural preservative free morphine with a continuous epidural fentanyl infusion The investigators will be comparing the patients pain level and satisfaction with the two techniques as well as the side effects that the patients experience such as itching nausea back pain and respiratory depression
Detailed Description:
Included in the study will be all healthy ASA I or II woman having elective Cesarean sections who are candidates for regional anesthesia Exclusion criteria include morbid obesity BMI 40 age less that 18 years history of sleep apnea and abuse of or intolerance to opioid analgesics
All patients will also receive 100 micrograms of fentanyl once epidurally during the Cesarean section and they will receive ibuprofen every six hours for the first 24 hours after the Cesarean section The patients will be visited twice a day postoperatively for two days The epidural morphine will be expected to last only approximately 20 hours while the fentanyl infusion will be kept in place for two days after the procedure Additional analgesics such as intravenous morphine or PO oxycodone and tylenol will be available for breakthrough pain
All patients will also receive 100 micrograms of fentanyl once epidurally during the Cesarean section and they will receive ibuprofen every six hours for the first 24 hours after the Cesarean section The patients will be visited twice a day postoperatively for two days The epidural morphine will be expected to last only approximately 20 hours while the fentanyl infusion will be kept in place for two days after the procedure Additional analgesics such as intravenous morphine or PO oxycodone and tylenol will be available for breakthrough pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None