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Dosage of Epidural Morphine in Elderly Patients

Primary Purpose

Age Problem, Abdominal Cancer

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

1.5 mg of Morphine Sulfate

Normal saline

3 mg of Morphine Sulfate

4.5 mg of Morphine Sulfate

About this trial

This is an interventional supportive care trial for Age Problem focused on measuring Injections, Epidural, Morphine Sulfate

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Assuit University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group D

Group A

Group B

Group C

Arm Description

where patients will receive epidural 15 ml of Marcaine 25% and and epinephrine 1:200,000.

where patients will receive epidural 15 ml volume of 1.5 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000.

where patients will receive epidural 15 ml volume of 3 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000.

where patients will receive epidural 15 ml volume of 4.5 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000.

Outcomes

Primary Outcome Measures

Total patient-controlled analgesia (PCA) morphine sulphate (MS) consumption.

It is an objective method to measure adequacy of pain control

Secondary Outcome Measures

Pain-intensity measured using visual analog scale (VAS)

It is a subjective scale to assess pain

Ramsay sedation scale (RSS).

It is a subjective scale to assess drowsiness

Nausea, vomiting and pruritis scale

It is a subjective scale to assess side effects of morphine

Full Information

NCT ID

NCT04316871

First Posted

March 19, 2020

Last Updated

June 2, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04316871

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

March 20, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age Problem, Abdominal Cancer

Keywords

Injections, Epidural, Morphine Sulfate

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group D

Arm Type

Placebo Comparator

Arm Description

where patients will receive epidural 15 ml of Marcaine 25% and and epinephrine 1:200,000.

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

where patients will receive epidural 15 ml volume of 1.5 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000.

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

where patients will receive epidural 15 ml volume of 3 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000.

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

where patients will receive epidural 15 ml volume of 4.5 mg morphine sulphate (MS), Marcaine 25% and and epinephrine 1:200,000.

Intervention Type

Drug

Intervention Name(s)

1.5 mg of Morphine Sulfate

Other Intervention Name(s)

Intervention Description

1.5 mg of Morphine Sulphate will be given epidurally.

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

Intervention Description

Normal saline will be given epidurally.

Intervention Type

Drug

Intervention Name(s)

3 mg of Morphine Sulfate

Other Intervention Name(s)

Intervention Description

3 mg of Morphine Sulphate will be given epidurally.

Intervention Type

Drug

Intervention Name(s)

4.5 mg of Morphine Sulfate

Other Intervention Name(s)

Intervention Description

4.5 mg of Morphine Sulphate will be given epidurally.

Primary Outcome Measure Information:

Title

Total patient-controlled analgesia (PCA) morphine sulphate (MS) consumption.

Description

It is an objective method to measure adequacy of pain control

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Pain-intensity measured using visual analog scale (VAS)

Description

It is a subjective scale to assess pain

Time Frame

72 hours

Title

Ramsay sedation scale (RSS).

Description

It is a subjective scale to assess drowsiness

Time Frame

72 hours

Title

Nausea, vomiting and pruritis scale

Description

It is a subjective scale to assess side effects of morphine

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diab Hetta, MD

Organizational Affiliation

Assiut University

Official's Role

Study Director

Facility Information:

Facility Name

Assuit University

City

Assuit

ZIP/Postal Code

71515

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26315638

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.

Results Reference

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PubMed Identifier

10735794

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.

Results Reference

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Dosage of Epidural Morphine in Elderly Patients

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