NCT00635986

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries. DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo. METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.

Conditions

• Fentanyl Analgesia

Interventions

Type	Name	Description
DRUG	Fentanyl	100 mcg Fentanyl intravenous or epidural route

Timeline

• Start date: 2004-05-01
• Primary completion: 2005-06-01
• Completion: 2006-11-01
• First posted: 2008-03-14
• Last updated: 2008-03-14