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

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.

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Key information

Conditions

Anesthesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Spinal Puncture

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Traumatology

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults
ASA I or II status
Scheduled for trauma or orthopedic surgeries of lower leg in spinal anesthesia

Exclusion criteria

Patients with scoliosis
Degenerative spine deformity
A history of back surgery or back pain
Pregnancy
Perence of coagulopathy
Systemic or local infection
Allergy to amide-local anesthetics
Neurologic damages and mental disability
More than one spinal puncture attempt
Patient who was unable to estimate pain score
High Ramsay sedation score

Treatment and study plan

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

Procedure

Sponsors and collaborators

Lead sponsor

Croatian Society of Regional Anesthesia and Analgesia

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 7, 2010
Registry last updated: Jul 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed