An interventional study of Oxycodone and Bupivacaine in Epidural, Oxycodone and Pain, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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.
Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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%.
Drug: Oxycodone
Patient will receive a bolus 20 ml bupivacaine 0.25% followed by an infusion 0.1 mL/Kg/h bupivacaine 0.125%.
Drug: Bupivacaine
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%.
Patient will receive a bolus 20 ml bupivacaine 0.25% followed by an infusion 0.1 mL/Kg/h bupivacaine 0.125%.
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
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
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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Kafrelsheikh University