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

July 6, 2010 updated by: Croatian Society of Regional Anesthesia and Analgesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital of Traumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group SNI
Insertion of spinal needle with introducer
Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
Other: Group SNI+LA
Local infiltration of lidocaine was applied three minutes after insertion of spinal needle with introducer
Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
Other: Group SNI+F
Intravenous fentanyl was applied 3 min before insertion of spinal needle with introducer
Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
Other: Group SN
Spinal puncture was performed only with spinal needle without introducer, local anesthetic infiltration or intravenous fentanyl before spinal puncture.
Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Croatian Society of Regional Anesthesia and Analgesia

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 7, 2010

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSRAA-CMA:007/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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