Epidural Oxycodone for Pain Management for Lower Limb Amputation

Kafrelsheikh University

Status: Enrolling

Conditions: Oxycodone; Lower Limb Amputation; Epidural; Pain

Treatments: Drug: Oxycodone; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06276179

KFSIRB200-97

Details and patient eligibility

About

The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation.

Full description

Phantom limb pain (PLP) is often described as tingling, throbbing, sharp, pins/needles in the limb that is no longer there. It occurs more commonly in upper extremity amputations than lower extremities and tends to be intermittent in frequency. Pain severity varies, and onset can be immediate or years afterward.

The preventive strategies for the PLP pain are difficult to manage and if not addressed adequately may lead to chronic pain. The perioperative role of the anesthesiologist and the acute pain physician is important in the management of somatic and sometimes neuropathic postoperative pain.

Oxycodone is a semi-synthetic narcotic analgesic and historically has been a popular drug of abuse among the narcotic abusing population. Oxycodone is used orally or intravenously.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status II or III.
• Undergoing lower limb amputation.
• Under epidural anesthesia.

Exclusion criteria

• Hypersensitivity to opioids.
• Cardiac arrhythmias.
• Acute asthma or other obstructive airways disease.
• Severe renal impairment.
• Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Oxycodone (study group)

Experimental group

Description:

Patient will receive a bolus dose of 0.15 mg/kg plus 20 ml bupivacaine 0.25% followed by an infusion 0.03 mg/kg/h oxycodone plus 0.1 mL/Kg/h bupivacaine 0.125%.

Treatment:

Drug: Oxycodone

Bupivacaine (control group)

Active Comparator group

Description:

Patient will receive a bolus 20 ml bupivacaine 0.25% followed by an infusion 0.1 mL/Kg/h bupivacaine 0.125%.

Treatment:

Drug: Bupivacaine