Dosage of Epidural Morphine in Elderly Patients

Abdominal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316871
• Other study ID #: EPMDose
• Status: Completed
• Phase: Phase 4
• Start date: March 20, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Cancer
• Abdominal Neoplasms
• Age Problem

Intervention

Drug:
• 1.5 mg of Morphine Sulfate
1.5 mg of Morphine Sulphate will be given epidurally.
• Normal saline
Normal saline will be given epidurally.
• 3 mg of Morphine Sulfate
3 mg of Morphine Sulphate will be given epidurally.
• 4.5 mg of Morphine Sulfate
4.5 mg of Morphine Sulphate will be given epidurally.

Locations

Country	Name	City	State
Egypt	Assuit University	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total patient-controlled analgesia (PCA) morphine sulphate (MS) consumption.	It is an objective method to measure adequacy of pain control	72 hours
Secondary	Pain-intensity measured using visual analog scale (VAS)	It is a subjective scale to assess pain	72 hours
Secondary	Ramsay sedation scale (RSS).	It is a subjective scale to assess drowsiness	72 hours
Secondary	Nausea, vomiting and pruritis scale	It is a subjective scale to assess side effects of morphine	72 hours