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

This study has been completed.
Sponsor:
Information provided by:
Croatian Society of Regional Anesthesia and Analgesia
ClinicalTrials.gov Identifier:
NCT01157247
First received: July 6, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Anesthesia
Spinal Puncture
Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Croatian Society of Regional Anesthesia and Analgesia:

Enrollment: 88
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group SNI
Insertion of spinal needle with introducer
Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
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
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
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

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157247

Locations
Croatia
University Hospital of Traumatology
Zagreb, Croatia, 10000
Sponsors and Collaborators
Croatian Society of Regional Anesthesia and Analgesia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01157247     History of Changes
Other Study ID Numbers: CSRAA-CMA:007/03
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: Croatia: Ethics Committee

Keywords provided by Croatian Society of Regional Anesthesia and Analgesia:
Anesthetic techniques
regional, spinal
Pain
lumbar puncture
Analgesia, local
Analgesia, intravenous

Additional relevant MeSH terms:
Anesthetics, Local
Anesthetics
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 21, 2014