Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01157247
Status:
COMPLETED
Last Update Posted:
2010-07-07
First Post:
2010-07-06
Brief Title:
Intravenous Fentanyl or Local Anesthetic Infiltration for Pain Reducing During Spinal Needle Insertion
Sponsor:
Croatian Society of Regional Anesthesia and Analgesia
Organization:
Croatian Society of Regional Anesthesia and Analgesia
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 III 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 25Gx114 needle or intravenous fentanyl application 0001 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 110
Methods Prospective randomized study included 88 adults 33-55 ages ASA III 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 25Gx114 needle or intravenous fentanyl application 0001 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 110
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None