Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
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
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.
Clinical Details
Official title: Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Pain relief
Secondary outcome: fentanyl plasma concentration measure in different times
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 2004
Ending date: November 2006
Last updated: March 11, 2008
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