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

NCT ID: NCT05782608

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-11-15

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.

Conditions

Ibuprofen; Ketorolac; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group (I)

Group Type: ACTIVE_COMPARATOR

IV ibuprofen

Intervention Type: DRUG

Group 1 will receive IV ibuprofen 400mg \\ 6 hours the first dose will be administrated immediately post operative.

group (II)

Group Type: ACTIVE_COMPARATOR

IV ketorolac

Intervention Type: DRUG

Group 2 will receive 20 mg IV ketorolac\\ 6 hours the first dose will be administrated immediately post operative

Interventions

IV ibuprofen

Group 1 will receive IV ibuprofen 400mg \\ 6 hours the first dose will be administrated immediately post operative.

Intervention Type: DRUG

IV ketorolac

Group 2 will receive 20 mg IV ketorolac\\ 6 hours the first dose will be administrated immediately post operative

Intervention Type: DRUG

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mahmoud Ismail Salama

Resident of anesthesia, SICU & Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Mahmoud Ismail Salama

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-503-2022

Identifier Type: -

Identifier Source: org_study_id