Clinical trial NCT04316871: Dosage of Epidural Morphine in Elderly Patients
Official title: Epidural Morphine for Geriatrics Undergoing Lower Abdominal Cancer Surgery: a Dose Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age Problem
Abdominal Cancer
Keywords: Injections, Epidural
Morphine Sulfate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized, double blinded, clinical trial was approved by the local ethics committee of faculty of medicine, Assuit University, Assuit, Egypt. The maximum total PCA morphine consumption was 12 ± 16 mg while in healthy controls was 70± 35 mg. We aim to enroll at least 60-80 participants considering the following assumptions:

* Main statistical test is ANOVA\\t-test to detect the difference of the difference of PCA morphine consumption between the four groups.
* Main outcome variable is total PCA morphine consumption after lower abdominal cancer surgery in elderly patients receiving three different doses of epidural morphine in comparison with its consumption in healthy controls not receiving epidural morphine.
* Effect size = 0.75, Alpha = 0.05, Power = 0.80
* Allocation ratio N4/N3/N2/N1 = 1/1/1/1.
* 22 patients should be enrolled in each group to account for dropouts.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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:

1. Patient refusal.
2. Patients who are morbidly obese (body mass index ≥ 40 kg/m2).
3. Those with contraindications to neuraxial analgesia. 4- psychiatric illness that would interfere with the perception and the assessment of pain.

Primary outcomes:
measure: Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption.
timeFrame: 72 hours
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 72 hours
measure: Modified Ramsay Sedation Scale
timeFrame: Modified Ramsay Sedation Scale at 2 hours postoperative
measure: Nausea Score
timeFrame: 72 hours
measure: Vomiting Score
timeFrame: 72 hours
measure: Pruritus Score
timeFrame: 72 hours
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit University
Study officials:
affiliation: Assiut University
name: Diab Hetta, MD
role: STUDY_DIRECTOR
References:
citation: McKeown JL. Pain Management Issues for the Geriatric Surgical Patient. Anesthesiol Clin. 2015 Sep;33(3):563-76. doi: 10.1016/j.anclin.2015.05.010. Epub 2015 Jul 3.
citation: Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.