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

Not Applicable

Completed

• Conditions: Anesthesia; Spinal Puncture
• Interventions: Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture

• Registration Number: NCT01157247
• Lead Sponsor: Croatian Society of Regional Anesthesia and Analgesia

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-06
• Last Update Submitted: 2010-07-06
• Study First Posted: 2010-07-07
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

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

Trial Locations

Locations (1)

University Hospital of Traumatology; 🇭🇷 Zagreb, Croatia