Dosage of Epidural Morphine in Elderly Patients

NCT04316871 | Completed Phase 4 Results

• 1 other identifier: EPMDose
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Age Problem; Abdominal Cancer

Keywords

Injections, Epidural; Morphine Sulfate

Outcome Measures

Primary Outcomes (1)

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

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

  72 hours

Secondary Outcomes (5)

• Visual Analog Scale

  72 hours

• Modified Ramsay Sedation Scale

  Modified Ramsay Sedation Scale at 2 hours postoperative

• Nausea Score

  72 hours

• Vomiting Score

  72 hours

• Pruritus Score

  72 hours

Study Arms (4)

Group D

PLACEBO COMPARATOR

A 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.

Drug: Normal saline

Group A

ACTIVE COMPARATOR

A 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.

Drug: 1.5 mg of Morphine Sulfate

Group B

ACTIVE COMPARATOR

A 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.

Drug: 3 mg of Morphine Sulfate

Group C

ACTIVE COMPARATOR

A 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.

Drug: 4.5 mg of Morphine Sulfate

Interventions

1.5 mg of Morphine Sulfate DRUG

1.5 mg of Morphine Sulphate will be given epidurally.

Also known as: A

Group A

Normal saline DRUG

Normal saline will be given epidurally.

Also known as: D

Group D

3 mg of Morphine Sulfate DRUG

3 mg of Morphine Sulphate will be given epidurally.

Also known as: B

Group B

4.5 mg of Morphine Sulfate DRUG

4.5 mg of Morphine Sulphate will be given epidurally.

Also known as: C

Group C

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Men and women aged ≥ 60 years, who are planned to undergo lower abdominal cancer surgery.
• ASA I and II classifications. 2. Surgeries via infra-umbilical abdominal incision is considered eligible.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University

Asyut, 71515, Egypt

Location

Related 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.

  PMID: 26315638 BACKGROUND

• 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.

  PMID: 10735794 BACKGROUND

MeSH Terms

Interventions

Morphine; Saline Solution; Fumigant 93

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

This study is limited by focusing on lower abdominal cancer surgeries only; also, it is a single center study. Therefore, the generalizability of our results is limited. Future large studies on different types of surgeries are needed. Due to the vulnerability of older adults, we assessed the balancing dose of epidural morphine versus age only. The relation between the dose of epidural morphine and common comorbidities in this age group should be investigated.

Results Point of Contact

• Title: Dr Muhammad Shawqi
• Organization: Assiut University

m.shawqi@med.au.edu.eg

01100671067

Study Officials

• Diab Hetta, MD

  Assiut University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia resident at South Egypt Cancer Institute

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 20, 2020
• Study Start: March 20, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will not be publicly available due to containing information that could compromise research participant privacy/consent.
• Access Criteria: The data will not be publicly available due to containing information that could compromise research participant privacy/consent.

Locations

EG (1)