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Trial record 7 of 11 for:    tenoxicam

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
Sponsor:
Information provided by:
Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Fentanyl Analgesia Drug: Fentanyl Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pain relief [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. fentanyl plasma concentration measure in different times [ Time Frame: 1year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Study Chair: Adriana M Issy, PhD Federal University of São Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: March 14, 2008
Last Verified: March 2008
Keywords provided by Federal University of São Paulo:
Analgesia
Fentanyl
Orthopedic
Mechanism of action
Surgery
Additional relevant MeSH terms:
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Fentanyl
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics