drugset / Trial / NCT04673812

Influence Of Low Dose Intrathecal Naloxone On Bupivacaine - Fentanyl Spinal Anaesthesia For Lower Limb Orthopedic Surgery In Elderly Patients

NCT04673812

RandomizedParallel-groupTriple-blindPrevention

Summary

Fentanyl is a safer alternative than morphine in the management of postoperative pain in elderly. However, pruritus, nausea and vomiting are unwanted side effects of intrathecal fentanyl administration, that can decrease patient satisfaction with anaesthesia, delay post anaesthesia care unit ( PACU ) discharge, and increase costs. The incidence of pruritus with neuraxial fentanyl is high. The incidence of pruritus in non-obstetric surgery patients after intrathecal fentanyl ranges from 53% to 79%. Naloxone hydrochloride is a pure opioid competitive antagonist. Small doses of naloxone may reduce Fentanyl-associated adverse effects, such as pruritus, nausea and vomiting without affecting analgesia.

Timeline

Start
2020-12-10
Primary completion
2021-03-10
Completion
2021-03-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naloxone Small molecule 20 ug Intrathecal
Comparator Bupivacaine Other / unclassified 12.5 mg Intrathecal
Comparator Fentanyl Other / unclassified 25 ug Intrathecal

Indications

No indication recorded.