Epidural Oxycodone for Pain Management for Lower Limb Amputation

NCT06276179 | Recruiting

• 1 other identifier: KFSIRB200-97
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epidural; Oxycodone; Pain; Lower Limb Amputation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to the first request for the rescue analgesia

  48 hours postoperatively

• Postoperative morphine consumption

  48 hours postoperatively

• Incidence of phantom limb pain

  3 months postoperatively

• Adverse effects

  48 hours postoperatively

Study Arms (2)

Oxycodone (study group)

EXPERIMENTAL

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

Bupivacaine (control group)

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

Oxycodone 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%.

Oxycodone (study group)

Bupivacaine DRUG

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

Bupivacaine (control group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status II or III.
• Undergoing lower limb amputation.
• Under epidural anesthesia.

You may not qualify if:

• Hypersensitivity to opioids.
• Cardiac arrhythmias.
• Acute asthma or other obstructive airways disease.
• Severe renal impairment.
• Pregnancy.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Oxycodone; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Gamal H Shams, MD

CONTACT

00201095927971; gamal.shams2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Postsurgical ICU, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 23, 2024
• Study Start: February 24, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)