Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

NCT00635986 | Completed DMC

• 2 other identifiers: FentanylNo grant
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fentanyl Analgesia

Keywords

Analgesia; Fentanyl; Orthopedic; Mechanism of action; Surgery

Outcome Measures

Primary Outcomes (1)

• Pain relief

  1 year

Secondary Outcomes (1)

• fentanyl plasma concentration measure in different times

  1year

Study Arms (1)

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

Interventions

Fentanyl DRUG

100 mcg Fentanyl intravenous or epidural route

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with infection in the puncture area and coagulation disorders, pregnant patients, and patients using opioids

Sponsors & Collaborators

• Federal University of São Paulo: lead

Related Publications (1)

• Privado MS, Issy AM, Lanchote VL, Garcia JB, Sakata RK. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial. Sao Paulo Med J. 2010 Jan;128(1):5-9. doi: 10.1590/s1516-31802010000100002.

  PMID: 20512273 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Adriana M Issy, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: March 14, 2008
• Study Start: May 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: November 1, 2006
• Last Updated: March 14, 2008

Record last verified: 2008-03