IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient
Primary Purpose
Ibuprofen, Ketorolac, Colorectal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IV ibuprofen
IV ketorolac
Sponsored by
About this trial
This is an interventional treatment trial for Ibuprofen
Eligibility Criteria
Inclusion Criteria: ASA class II. Age ≥ 18 and ≤ 65 Years. Patients undergoing midline abdominal incision for colorectal cancer surgery. Body mass index (BMI) >30 kg/m2. Exclusion Criteria: Renal and hepatic insufficiency. Unstable cardiovascular disease. History of psychiatric and cognitive disorders. Patients allergic to medication used. Asthmatic patients. Peptic ulcer patients. patients on regular opioid consumption. History of allergy or hypersensitivity to any component of ibuprofen, other NSAIDs, opioids or COX- 2 inhibitors. Subjects with active significant anemia, history of asthma .
Sites / Locations
- Ahmed Mahmoud Ismail Salama
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group (I)
group (II)
Arm Description
Outcomes
Primary Outcome Measures
Assessment of Pain
Pain using visual analogue score (VAS score), Using a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05782608
Brief Title
IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient
Official Title
Efficacy of IV Ibuprofen vs Ketorolac in Controlling Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient: A Randomized Double Blinded Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ibuprofen, Ketorolac, Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group (I)
Arm Type
Active Comparator
Arm Title
group (II)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IV ibuprofen
Intervention Description
Group 1 will receive IV ibuprofen 400mg \ 6 hours the first dose will be administrated immediately post operative.
Intervention Type
Drug
Intervention Name(s)
IV ketorolac
Intervention Description
Group 2 will receive 20 mg IV ketorolac\ 6 hours the first dose will be administrated immediately post operative
Primary Outcome Measure Information:
Title
Assessment of Pain
Description
Pain using visual analogue score (VAS score), Using a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA class II.
Age ≥ 18 and ≤ 65 Years.
Patients undergoing midline abdominal incision for colorectal cancer surgery.
Body mass index (BMI) >30 kg/m2.
Exclusion Criteria:
Renal and hepatic insufficiency.
Unstable cardiovascular disease.
History of psychiatric and cognitive disorders.
Patients allergic to medication used.
Asthmatic patients.
Peptic ulcer patients.
patients on regular opioid consumption.
History of allergy or hypersensitivity to any component of ibuprofen, other NSAIDs, opioids or COX- 2 inhibitors.
Subjects with active significant anemia, history of asthma .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Salama, Master
Phone
01024275085
Ext
02
Email
dr.ahmed.ismail1993@gmail.com
Facility Information:
Facility Name
Ahmed Mahmoud Ismail Salama
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Salama, Master
Phone
01024275085
Ext
02
Email
dr.ahmed.ismail1993@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon reasonable request from the principal investigator
IPD Sharing Time Frame
one year
Learn more about this trial
IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient
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