Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl (FTN)
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|ClinicalTrials.gov Identifier: NCT00635986|
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : March 14, 2008
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 or disease||Intervention/treatment||Phase|
|Fentanyl Analgesia||Drug: Fentanyl||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||November 2006|
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
100 mcg Fentanyl intravenous or epidural route
- Pain relief [ Time Frame: 1 year ]
- fentanyl plasma concentration measure in different times [ Time Frame: 1year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635986
|Study Chair:||Adriana M Issy, PhD||Federal University of São Paulo|