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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06276179
Other study ID # KFSIRB200-97
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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