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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
96
1.5 mg of Morphine Sulphate will be given epidurally.
Normal saline will be given epidurally.
3 mg of Morphine Sulphate will be given epidurally.
Assuit University
Asyut, Egypt
Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption.
The mean total PCA morphine consumption (mg) in the first 72 hr. postoperatively
Time frame: 72 hours
Visual Analog Scale
Visual Analog Scale is a visual chart scored from 0 (no pain) to 10 ( the worst pain ever) used by the patient to report the severity of their pain to assess the pain intensity, and all patients were instructed how to evaluate their pain and how to use the patient-controlled analgesia.
Time frame: 72 hours
Modified Ramsay Sedation Scale
It is an six-point scale informed by degree of responsiveness to verbal and tactile stimulus where awake levels were as follows: I = anxious, agitated, or restless; II = cooperative, oriented, and tranquil; III = response to command, and asleep levels were dependent on the patient's response to a light glabellar tap or loud auditory stimulus; IV = brisk response; V = a sluggish response; and VI = no response
Time frame: Modified Ramsay Sedation Scale at 2 hours postoperative
Nausea Score
It is a subjective scale to assess the nauseating side effects of morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Nausea scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent; 1. if the side effect was minimal and did not require treatment; 2. if the side effect was moderate or severe and required treatment.
Time frame: 72 hours
Vomiting Score
It is a subjective scale to assess the vomiting as a side effect of epidural morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Vomiting scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent; 1. if the side effect was minimal and did not require treatment; 2. if the side effect was moderate or severe and required treatment.
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4.5 mg of Morphine Sulphate will be given epidurally.
Time frame: 72 hours
Pruritus Score
It is a subjective scale to assess the pruritus as a side effect of morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Pruritus scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent; 1. if the side effect was minimal and did not require treatment; 2. if the side effect was moderate or severe and required treatment.
Time frame: 72 hours