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

Study Overview
=================
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.

Conditions
-----------------
Anesthesia, Spinal Puncture

Intervention / Treatment
-----------------
* Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group SNI<br>Insertion of spinal needle with introducer | Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture<br> <br> |
| Other: Group SNI+LA<br>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<br> <br> |
| Other: Group SNI+F<br>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<br> <br> |
| Other: Group SN<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthetic techniques, regional, spinal, Pain, lumbar puncture, Analgesia, local, Analgesia, intravenous