Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05782608 |
Other study ID # |
MS-503-2022 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2023 |
Est. completion date |
November 15, 2023 |
Study information
Verified date |
January 2024 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to assess the Efficacy of IV Ibuprofen and Ketorolac in the
Management of Postoperative Pain in obese patients Following abdominal cancer surgery.
Description:
Colorectal cancer is the third most common cancer in the world, after lung and breast cancer,
and the 4th most reported cause of cancer death, reporting about 8.0 % of all cancer deaths
According to the WHO, Egypt was ranked the 18th regarding the prevalence of obesity, and
Deaths attributable to non-communicable diseases represent about 71% of the total mortality
burden.Data obtained from the past 25 years suggest that the obesity is a cause of nearly 14%
of cancer deaths in men and up to 20% of cancer deaths in women. Most of cases experience
moderate to severe pain after colorectal surgery, So effective and individualized analgesia
required after colorectal surgery, as pain response to surgery is not predicted.
Opioids are an effective analgesic for moderate to severe pain, although their efficacy is
limited by adverse effects including respiratory depression, failure to reduce pain caused by
tissue inflammation, nausea, emesis, drowsiness, moderate sedation, pruritus, urinary
retention and ileus.
Regional anesthesia can be an alternative to opioids but according to multiple studies it was
associated with technical difficulties and higher failure rates in obese patients. Ibuprofen
is a nonselective inhibitor of cyclooxygenases (COX) enzymes, the inhibition ratio of COX-1
to COX 2 of Ibuprofen is 2,5:1 that has a low risk of bleeding or gastrointestinal problems,
while other NSAID as for example ketorolac have an inhibition ratio of 330:1 for COX-1 to
COX-2 , reason for a high risk of side effects , therefore its use is controversial in most
of perioperative settings. ketorolac 10 and 20 mg and ibuprofen 400 mg have the same
analgesic effect that was significant by hour 1 and persisted for 5-6 hours for each active
medication.