Epidural Oxycodone for Pain Management for Lower Limb Amputation

NCT ID: NCT06276179

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-24
• Study Completion Date: 2024-08-01

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.

Conditions

Epidural; Oxycodone; Pain; Lower Limb Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxycodone (study group)

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%.

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

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 (control group)

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Interventions

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%.

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Gamal Hendawy Shams

Lecturer of Anesthesia and Postsurgical ICU, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Gamal H Shams, MD

Role: CONTACT

gamal.shams2@gmail.com

00201095927971

Facility Contacts

Gamal H Shams, MD

Role: primary

gamal.shams2@gmail.com

00201095927971

Other Identifiers

KFSIRB200-97

Identifier Type: -

Identifier Source: org_study_id