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Completed

NCT Number: NCT04316871

Dosage of Epidural Morphine in Elderly Patients

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

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Key information

Conditions

Age Problem Abdominal Cancer

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assuit University

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

1.5 mg of Morphine Sulfate

Drug

1.5 mg of Morphine Sulphate will be given epidurally.

Other names: A

normal saline

Drug

Normal saline will be given epidurally.

Other names: D

3 mg of Morphine Sulfate

Drug

3 mg of Morphine Sulphate will be given epidurally.

Other names: B

4.5 mg of Morphine Sulfate

Drug

4.5 mg of Morphine Sulphate will be given epidurally.

Other names: C

Primary outcomes

  1. Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption.

    Time frame: 72 hours

    The mean total PCA morphine consumption (mg) in the first 72 hr. postoperatively

Secondary outcomes

  1. Visual Analog Scale

    Time frame: 72 hours

    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.

  2. Modified Ramsay Sedation Scale

    Time frame: Modified Ramsay Sedation Scale at 2 hours postoperative

    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

  3. Nausea Score

    Time frame: 72 hours

    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;

    • if the side effect was minimal and did not require treatment;
    • if the side effect was moderate or severe and required treatment.

  4. Vomiting Score

    Time frame: 72 hours

    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;

    • if the side effect was minimal and did not require treatment;
    • if the side effect was moderate or severe and required treatment.

  5. Pruritus Score

    Time frame: 72 hours

    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;

    • if the side effect was minimal and did not require treatment;
    • if the side effect was moderate or severe and required treatment.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 20, 2020
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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