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AzTrials

Age ProblemPhase 4NCT04316871

Dosage of Epidural Morphine in Elderly Patients

A Phase 4 study testing 1.5 mg of Morphine Sulfate, Normal saline and 3 mg of Morphine Sulfate in people with Age Problem and Abdominal Cancer, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 60 to 100 years
Conditions the study is for
Age Problem, Abdominal Cancer
What is being tested?
1.5 mg of Morphine Sulfate, Normal saline and 3 mg of Morphine Sulfate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteEgypt
Study dates
20 Mar 2020to 30 Jun 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assuit University

    Asyut, 71515

Other trials in Egypt

About this study

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

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

Read the 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.

Being tested
1.5 mg of Morphine Sulfate, Normal saline, 3 mg of Morphine Sulfate, 4.5 mg of Morphine Sulfate
Keywords
Injections, Epidural, Morphine Sulfate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1.5 mg of Morphine SulfateDrug

    Also called A

    1.5 mg of Morphine Sulphate will be given epidurally.

  • Normal salineDrug

    Also called D

    Normal saline will be given epidurally.

  • 3 mg of Morphine SulfateDrug

    Also called B

    3 mg of Morphine Sulphate will be given epidurally.

  • 4.5 mg of Morphine SulfateDrug

    Also called C

    4.5 mg of Morphine Sulphate will be given epidurally.

Study groups in NCT04316871
Study groupRoleWhat they receive
Group DPlacebo comparatorA total volume of 10 mL injection 5 mL of bupivacaine hydrochloride 0.125% diluted in 5 mL preservative-free normal saline by the hospital pharmacist.
Receives: Drug: Normal saline
Group AActive comparatorA total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 1.5 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist.
Receives: Drug: 1.5 mg of Morphine Sulfate
Group BActive comparatorA total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 3 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist.
Receives: Drug: 3 mg of Morphine Sulfate
Group CActive comparatorA total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 4 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist.
Receives: Drug: 4.5 mg of Morphine Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 72 hours

Secondary outcomes (5)

  1. 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.

    Measured: 72 hours

  2. 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

    Measured: Modified Ramsay Sedation Scale at 2 hours postoperative

  3. 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.

    Measured: 72 hours

  4. 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.

    Measured: 72 hours

  5. 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.

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2020
  2. Study start20 Mar 2020
  3. Primary completion31 Dec 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04316871
Sponsor's protocol ID
EPMDose
Status last verified
Feb 2025
First submitted
19 Mar 2020
Last updated
5 Mar 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request. The data will not be publicly available due to containing information that could compromise research participant privacy/consent.

Publications

  • 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.

    PubMed 26315638

  • 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.

    PubMed 10735794

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 1.5 mg of Morphine Sulfate, Normal saline and 3 mg of Morphine Sulfate in people with Age Problem and Abdominal Cancer, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption. (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04316871, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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