Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Federal University of São Paulo0 sites30 target enrollmentMay 2004

ConditionsFentanyl Analgesia

InterventionsFentanyl

DrugsFentanyl

Overview

Phase: Not Applicable
Intervention: Fentanyl
Conditions: Fentanyl Analgesia
Sponsor: Federal University of São Paulo
Enrollment: 30
Primary Endpoint: Pain relief
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

November 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

•Both genders ranging in age from 18 to 65 years, American Society of Anesthesiologists (ASA) Physical Status 1 or 2, scheduled for orthopedic bone surgery of the lower limbs

Exclusion Criteria

•Patients with infection in the puncture area and coagulation disorders, pregnant patients, and patients using opioids

Arms & Interventions

A

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

Intervention: Fentanyl