FTN: Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00635986

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 1, 2004

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain relief [1 year]

Secondary Outcome Measures

fentanyl plasma concentration measure in different times [1year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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