Epidural Oxycodone for Pain Management for Lower Limb Amputation

Pain Clinical Trial

Official title:

Epidural Oxycodone for Pain Management for Lower Limb Amputation: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276179
• Other study ID #: KFSIRB200-97
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Kafrelsheikh University
• Contact: Gamal H Shams, MD
• Phone: 00201095927971
• Email: gamal.shams2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epidural
• Lower Limb Amputation
• Oxycodone
• Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours postoperatively
Secondary	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.	48 hours postoperatively
Secondary	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.	48 hours postoperatively
Secondary	Incidence of phantom limb pain	Incidence of phantom limb pain will be assessed 3 months after surgery	3 months postoperatively
Secondary	Adverse effects	Adverse effects such as postoperative nausea and vomiting, pruritus, urinary retention, constipation, and respiratory depression will be recorded.	48 hours postoperatively