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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ibuprofen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 11, 2023
Last Updated
March 11, 2023
Sponsor
Cairo University
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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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