Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02091297
Status:
WITHDRAWN
Last Update Posted:
2016-08-05
First Post:
2014-03-10
Brief Title:
Comparison of Different Methods of Pain Control After Cesarean Section for Patients on Buprenorphine or Methadone
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Comparison of Transversus Abdominis Plane Block Versus Patient-controlled Epidural Analgesia for Patients on Buprenorphine or Methadone After Cesarean Section
Status:
WITHDRAWN
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
two other institutions that were in the center thought they werent going to be able to recruit enough patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
More and more women are on buprenorphine or methadone during pregnancy for a history of opioid addiction Currently pain control after cesarean section for women already on these medications if they need operative delivery is a challenge due to the pharmacology of those drugs They have higher pain scores and 45-47 higher opiates requirement To improve pain control some unique regional anesthesia techniques have been employed besides opioid and non-opioid medication management through the oral intravenous andor neuraxial spinal or epidural route One is a TAP block transversus abdominis plane block a regional anesthesia procedure in which long acting local anesthetic such as ropivacaine is injected on both sides of the patients abdomen to numb the nerves supplying the abdominal wall or the surgical site Another is a patient - controlled epidural a small flexible catheter that is inserted in the back into the epidural space near the spine which bathes the spinal nerve roots with long acting local anesthetic such as bupivacaine and with an opioid such as fentanyl to numb the nerves going to the surgical site Through an epidural pump the patient receives a continuous infusion of local anesthetic and can delivery more medication as needed through a bolus feature There have case reports or case by case accounts of these techniques and it is suspected these techniques result in better pain control with minimal side effects No clinical human or animal has evaluated these techniques in a controlled and through manner either comparing the two techniques to each other or comparing them to the common care of opioid and non-opioid medication management through the oral intravenous andor neuraxial route including neuraxial hydromorphone or morphine
Detailed Description:
None
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