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Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fentanyl Analgesia

Intervention: Fentanyl (Drug)

Phase: N/A

Status: Completed

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Adriana M Issy, PhD, Study Chair, Affiliation: Federal University of São Paulo


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.

Clinical Details

Official title: Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pain relief

Secondary outcome: fentanyl plasma concentration measure in different times


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: May 2004
Last updated: March 11, 2008

Page last updated: August 23, 2015

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