Dosage of Epidural Morphine in Elderly Patients

Assiut University

Status and phase: Completed; Phase 4

Conditions: Abdominal Cancer; Age Problem

Treatments: Drug: 3 mg of Morphine Sulfate; Drug: Normal saline; Drug: 4.5 mg of Morphine Sulfate; Drug: 1.5 mg of Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04316871

EPMDose

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No 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

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 4 patient groups, including a placebo group

Group D

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline

Group A

Active Comparator group

Description:

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.

Treatment:

Drug: 1.5 mg of Morphine Sulfate

Group B

Active Comparator group

Description:

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.

Treatment:

Drug: 3 mg of Morphine Sulfate

Group C

Active Comparator group

Description:

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.

Treatment:

Drug: 4.5 mg of Morphine Sulfate