Intravenous Fentanyl or Local Anesthetic Infiltration for Pain Reducing During Spinal Needle Insertion
NCT ID: NCT01157247
Last Updated: 2010-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2009-04-30
2010-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Study Groups
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Group SNI
Insertion of spinal needle with introducer
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
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
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.
Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
Interventions
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Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
Eligibility Criteria
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Inclusion Criteria
* ASA I or II status
* Scheduled for trauma or orthopedic surgeries of lower leg in spinal anesthesia
Exclusion Criteria
* 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
35 Years
55 Years
ALL
No
Sponsors
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Croatian Society of Regional Anesthesia and Analgesia
OTHER
Locations
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University Hospital of Traumatology
Zagreb, , Croatia
Countries
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References
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Almeida GP, Boos GL, Alencar TG, Oliveira Filho GR. [Onset of 1% lidocaine for skin infiltrative anesthesia]. Rev Bras Anestesiol. 2005 Jun;55(3):284-8. doi: 10.1590/s0034-70942005000300005. Portuguese.
Kaur G, Gupta P, Kumar A. A randomized trial of eutectic mixture of local anesthetics during lumbar puncture in newborns. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1065-70. doi: 10.1001/archpedi.157.11.1065.
Calderon E, Pernia A, Roman MD, Perez AC, Torres LM. [Analgesia and sedation in the subarachnoid anesthesia technique: comparative study between remifentanil and fentanyl/midazolam]. Rev Esp Anestesiol Reanim. 2003 Mar;50(3):121-5. Spanish.
Other Identifiers
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CSRAA-CMA:007/03
Identifier Type: -
Identifier Source: org_study_id
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