Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl - Tabular View

Tracking Information

First Received Date ^ICMJE

January 14, 2008

Last Updated Date

March 11, 2008

Start Date ^ICMJE

May 2004

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain relief [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00635986 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

fentanyl plasma concentration measure in different times [ Time Frame: 1year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Official Title ^ICMJE

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Fentanyl Analgesia

Intervention ^ICMJE

Drug: Fentanyl

Study Arms / Comparison Groups

Experimental: 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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00635986

Responsible Party

Adriana Machado Issy/ Professor, Universidade Federal de São Paulo

Study ID Numbers ^ICMJE

Fentanyl, No grant

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Adriana M Issy, PhD

Federal University of São Paulo

Information Provided By

Federal University of São Paulo

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP