Dosage of Epidural Morphine in Elderly Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Age Problem, Abdominal Cancer

Intervention / Treatment
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* Drug: 1.5 mg of Morphine Sulfate
* Drug: Normal saline
* Drug: 3 mg of Morphine Sulfate
* Drug: 4.5 mg of Morphine Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Men and women aged ≥ 60 years, who are planned to undergo lower abdominal cancer surgery. 2- ASA I and II classifications. 2. Surgeries via infra-umbilical abdominal incision is considered eligible. Exclusion Criteria: Patient refusal. Patients who are morbidly obese (body mass index ≥ 40 kg/m2). Those with contraindications to neuraxial analgesia. 4- psychiatric illness that would interfere with the perception and the assessment of pain.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group D<br>where patients will receive epidural 15 ml of Marcaine 25% and and epinephrine 1:200,000. | Drug: Normal saline<br>* Normal saline will be given epidurally.<br>* Other names: D;|
| Active Comparator: Group A<br>where patients will receive epidural 15 ml volume of 1.5 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000. | Drug: 1.5 mg of Morphine Sulfate<br>* 1.5 mg of Morphine Sulphate will be given epidurally.<br>* Other names: A;|
| Active Comparator: Group B<br>where patients will receive epidural 15 ml volume of 3 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000. | Drug: 3 mg of Morphine Sulfate<br>* 3 mg of Morphine Sulphate will be given epidurally.<br>* Other names: B;|
| Active Comparator: Group C<br>where patients will receive epidural 15 ml volume of 4.5 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000. | Drug: 4.5 mg of Morphine Sulfate<br>* 4.5 mg of Morphine Sulphate will be given epidurally.<br>* Other names: C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total patient-controlled analgesia (PCA) morphine sulphate (MS) consumption. | It is an objective method to measure adequacy of pain control | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-intensity measured using visual analog scale (VAS) | It is a subjective scale to assess pain | 72 hours | 
| Ramsay sedation scale (RSS). | It is a subjective scale to assess drowsiness | 72 hours | 
| Nausea, vomiting and pruritis scale | It is a subjective scale to assess side effects of morphine | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injections, Epidural, Morphine Sulfate