IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05782608
• Other study ID #: MS-503-2022
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Ibuprofen
• Pain, Postoperative

Intervention

Drug:
• IV ibuprofen
Group 1 will receive IV ibuprofen 400mg \ 6 hours the first dose will be administrated immediately post operative.
• IV ketorolac
Group 2 will receive 20 mg IV ketorolac\ 6 hours the first dose will be administrated immediately post operative

Locations

Country	Name	City	State
Egypt	Ahmed Mahmoud Ismail Salama	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	During procedure