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Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl (FTN)

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00635986
First received: January 14, 2008
Last updated: March 11, 2008
Last verified: March 2008
History of Changes

January 14, 2008
March 11, 2008
May 2004
June 2005   (final data collection date for primary outcome measure)
Pain relief [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00635986 on ClinicalTrials.gov Archive Site
fentanyl plasma concentration measure in different times [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fentanyl Analgesia
Drug: Fentanyl
100 mcg Fentanyl intravenous or epidural route
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
Intervention: Drug: Fentanyl
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2006
June 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00635986
Fentanyl, No grant
Yes
Adriana Machado Issy/ Professor, Universidade Federal de São Paulo
Federal University of São Paulo
Not Provided
Study Chair: Adriana M Issy, PhD Federal University of São Paulo
Federal University of São Paulo
March 2008

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