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

Efficacy of IV Ibuprofen vs Ketorolac in Controlling Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient: A Randomized Double Blinded Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Ibuprofen; Ketorolac
• Intervention / Treatment: Drug: IV ibuprofen; Drug: IV ketorolac

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Ahmed Mahmoud Ismail Salama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group (I)	Drug: IV ibuprofen; Group 1 will receive IV ibuprofen 400mg \ 6 hours the first dose will be administrated immediately post operative.
Active Comparator: group (II)	Drug: IV ketorolac; Group 2 will receive 20 mg IV ketorolac\ 6 hours the first dose will be administrated immediately post operative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 11, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Pain, Postoperative; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ibuprofen
• Other Study ID Numbers: MS-503-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principal investigator
• IPD Sharing Time Frame: one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No