Clinical Trials Directory

Trials / Completed

CompletedNCT01157247

Intravenous Fentanyl or Local Anesthetic Infiltration for Pain Reducing During Spinal Needle Insertion

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
88 (actual)
Sponsor
Croatian Society of Regional Anesthesia and Analgesia · Academic / Other
Sex
All
Age
35 Years – 55 Years
Healthy volunteers
Not accepted

Summary

Background and Objectives: Spinal puncture is painful procedure which may cause patient refusal of spinal anesthesia in future surgery. It could be minimized with topical and infiltration local anesthetic or intravenous opioid application before procedure. Objective was efficacy of intravenous fentanyl in alleviating pain during spinal needle insertion. Methods: Prospective, randomized study included 88 adults (33-55 ages, ASA I/II), scheduled for lower leg surgery. Patients were divided in four equal study groups: spinal needle (Quincke, 26G) with introducer (20G) was inserted alone, three minutes after local anesthetic infiltration (2 ml of 2% lidocaine, 25Gx11/4" needle) or intravenous fentanyl application (0.001 mg kg-1) and without local anesthetic, fentanyl and introducer. Pain was assessed immediately after procedure by VAS score. MAP, HR and SaO2 were recorded. Sedation was assessed by Ramsay score. Statistical analysis was performed by SPSS 11.0.

Conditions

Interventions

TypeNameDescription
PROCEDUREComparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture

Timeline

Start date
2009-04-01
Primary completion
2010-06-01
Completion
2010-07-01
First posted
2010-07-07
Last updated
2010-07-07

Locations

1 site across 1 country: Croatia

Source: ClinicalTrials.gov record NCT01157247. Inclusion in this directory is not an endorsement.