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

Croatian Society of Regional Anesthesia and Analgesia

Status: Completed

Conditions: Spinal Puncture; Anesthesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01157247

CSRAA-CMA:007/03

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

88 participants in 4 patient groups

Group SNI

Other group

Description:

Insertion of spinal needle with introducer

Treatment:

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

Group SNI+LA

Other group

Description:

Local infiltration of lidocaine was applied three minutes after insertion of spinal needle with introducer

Treatment:

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

Group SNI+F

Other group

Description:

Intravenous fentanyl was applied 3 min before insertion of spinal needle with introducer

Treatment:

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

Group SN

Other group

Description:

Spinal puncture was performed only with spinal needle without introducer, local anesthetic infiltration or intravenous fentanyl before spinal puncture.

Treatment:

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