Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT02893423 |
Other study ID # |
Study # 13/01/VA01 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2013 |
Est. completion date |
September 30, 2016 |
Study information
Verified date |
May 2022 |
Source |
Maimonides Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
With this research the investigators hope to determine the lowest dose of ropivacaine used in
transversus abdominis plane (TAP) blocks that can effectively treat pain in women after
cesarean section (c-section).
Description:
With this research the investigators hope to determine the lowest dose of ropivacaine used in
transversus abdominis plane (TAP) blocks that can effectively treat pain in women after
cesarean section (c-section). The TAP is a space between the muscle layers of the abdominal
wall that houses nerves supplying the abdominal skin. The investigators will inject the local
anesthetic ropivacaine into this space to freeze these nerves and prevent pain following
c-section. The investigators will compare three different doses of ropivacaine (0.5%, 0.25%,
0%) to determine the lowest dose that controls pain with the fewest side effects.
Participants in this study will receive 0.5% (Group 1), 0.25% (Group 2), or 0% (Group 3)
ropivacaine TAP blocks to control pain after c-section. At 2, 6, 12, 24, and 48 hours after
cesarean section visual analog pain scores (VAS) for pain on movement, pain at rest, and pain
with cough will be collected along with the time to first postoperative analgesic request,
patient satisfaction scores, and patient demographics. The analgesic regimen will be
considered effective if it provides lower average visual analog scores for pain with
movement. Secondary outcomes will be higher patient satisfaction, better pain control, fewer
postoperative analgesic requests, and fewer side effects.