NCT04316871

Dosage of Epidural Morphine in Elderly Patients

Epidural Morphine for Geriatrics Undergoing Lower Abdominal Cancer Surgery: a Dose Response Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This a clinical trial that evaluates the efficacy and safety of three different doses of morphine, namely 1.5 mg, 3 mg and 4.5 mg, via the epidural route regarding reducing pain in elderly patients after a cancer surgery in the lower abdomen

Detailed description

Acute postoperative pain is a common complaint for several days after surgery. However, acute postoperative pain remains even more under controlled in elderly patients, especially those with cognitive impairment and malignancy. Geriatric population is reported to be at higher risk for unwanted side effects from analgesic treatments compared to younger patients due to different major risk factors such as: decline in organ function, polypharmacy, pharmacokinetics, drug sensitivity, and frailty. Despite of the higher risk of opioids, especially morphine, causing toxicity and adverse effect; they are still the cornerstone treatment of severe acute postoperative pain. Morphine in those patients is very likely to cause toxicity because of accumulation of its active metabolites compared to other opioids with fewer or no active metabolites. Epidural morphine is an effective route for an effective drug. Furthermore, unwanted side effects with neuraxial opioids are minor and managed easily. Regarding clinical outcomes, clinical studies showed a lot of improvements associated with postoperative opioid analgesia. Now, there is a clinical necessity to achieve the best management of acute postoperative pain in elderly patients with the least possibility of adverse side effects. We aim in this randomized, assessor blinded, clinical trial at Assuit University to determine the optimum dose of epidural morphine for the highest control of acute postoperative pain in geriatrics who are planned to have lower abdominal cancer surgery.

Conditions

• Age Problem
• Abdominal Cancer

Interventions

Type	Name	Description
DRUG	1.5 mg of Morphine Sulfate	1.5 mg of Morphine Sulphate will be given epidurally.
DRUG	Normal saline	Normal saline will be given epidurally.
DRUG	3 mg of Morphine Sulfate	3 mg of Morphine Sulphate will be given epidurally.
DRUG	4.5 mg of Morphine Sulfate	4.5 mg of Morphine Sulphate will be given epidurally.

Timeline

• Start date: 2020-03-20
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2020-03-20
• Last updated: 2025-03-05
• Results posted: 2025-03-05

Locations

1 site across 1 country: Egypt