Epidural, Lower Limb Amputation, Oxycodone, Pain
Conditions
Brief summary
The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation.
Detailed 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.
Interventions
DRUGOxycodone
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%.
DRUGBupivacaine
Patient will receive a bolus 20 ml bupivacaine 0.25% followed by an infusion 0.1 mL/Kg/h bupivacaine 0.125%.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute postoperative pain scores | 48 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first request for the rescue analgesia | 48 hours postoperatively | 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. |
| Postoperative morphine consumption | 48 hours postoperatively | 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. |
| Incidence of phantom limb pain | 3 months postoperatively | Incidence of phantom limb pain will be assessed 3 months after surgery |
| Adverse effects | 48 hours postoperatively | Adverse effects such as postoperative nausea and vomiting, pruritus, urinary retention, constipation, and respiratory depression will be recorded. |
Countries
Egypt
Contacts
Primary ContactGamal H Shams, MD
Outcome results
None listed