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

Sponsor:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00635986

Purpose

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.

Condition	Intervention
Fentanyl Analgesia	Drug: Fentanyl

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Resource links provided by NLM:

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	30
Study Start Date:	May 2004
Study Completion Date:	November 2006
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Drug: Fentanyl 100 mcg Fentanyl intravenous or epidural route

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635986

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Study Chair:

Adriana M Issy, PhD

Federal University of São Paulo

More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Privado MS, Issy AM, Lanchote VL, Garcia JB, Sakata RK. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial. Sao Paulo Med J. 2010 Jan;128(1):5-9.

Responsible Party:	Adriana Machado Issy/ Professor, Universidade Federal de São Paulo
ClinicalTrials.gov Identifier:	NCT00635986 History of Changes
Other Study ID Numbers:	Fentanyl, No grant
Study First Received:	January 14, 2008
Last Updated:	March 11, 2008
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

Analgesia
Fentanyl
Orthopedic
Mechanism of action
Surgery

Additional relevant MeSH terms:

Analgesics
Fentanyl
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Adjuvants, Anesthesia
Narcotics
Central Nervous System Depressants
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012