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| 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: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacodynamics Study |
| Official Title: | Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl |
| 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 |
|---|---|
|
A: 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Universidade Federal de São Paulo ( Adriana Machado Issy/ Professor ) |
| Study ID Numbers: | Fentanyl, No grant |
| Study First Received: | January 14, 2008 |
| Last Updated: | March 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00635986 History of Changes |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
Analgesia Fentanyl Orthopedic Mechanism of action Surgery |
|
Anesthetics, Intravenous Fentanyl Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
