Epidural Oxycodone for Pain Management for Lower Limb Amputation

Kafrelsheikh University40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Epidural Oxycodone Pain Lower Limb Amputation

Interventions

OxycodoneDRUG

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%.

BupivacaineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

RECRUITING

Outcomes

Primary Outcomes

Acute postoperative pain scores

Acute postoperative pain scores will be assessed using numerical rating scale (NRS).Each patient will be instructed about postoperative pain assessment with NRS. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at PACU, 2, 4, 6, 12, 24, 36 and 48 h postoperatively.

Time frame: 48 hours postoperatively

Secondary Outcomes

Time to the first request for the rescue analgesia

Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated). If numerical rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia.

Time frame: 48 hours postoperatively

Postoperative morphine consumption

Acute postoperative pain scores will be assessed using numerical rating scale (NRS). NRS will be assessed at PACU, 2, 4, 6, 12, 24, 36 and 48 h postoperatively. A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If NRS is more than 3, intravenous morphine 3mg will be administered as rescue analgesia.

Time frame: 48 hours postoperatively

Incidence of phantom limb pain

Incidence of phantom limb pain will be assessed 3 months after surgery

Time frame: 3 months postoperatively

Adverse effects

Adverse effects such as postoperative nausea and vomiting, pruritus, urinary retention, constipation, and respiratory depression will be recorded.

Time frame: 48 hours postoperatively

Central Contacts

Gamal H Shams, MD

CONTACT

00201095927971 gamal.shams2@gmail.com

Data from ClinicalTrials.gov

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