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Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00635986
Acronym
FTN
Enrollment
30
Registered
2008-03-14
Start date
2004-05-31
Completion date
2006-11-30
Last updated
2008-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fentanyl Analgesia

Keywords

Analgesia, Fentanyl, Orthopedic, Mechanism of action, Surgery

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.

Interventions

DRUGFentanyl

100 mcg Fentanyl intravenous or epidural route

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain relief1 year

Secondary

MeasureTime frame
fentanyl plasma concentration measure in different times1year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026