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

NCT01157247 | Completed DMC

• 1 other identifier: CSRAA-CMA:007/03
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Keywords

Anesthetic techniques; regional, spinal; Pain; lumbar puncture; Analgesia, local; Analgesia, intravenous

Study Arms (4)

Group SNI

OTHER

Insertion of spinal needle with introducer

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

Group SNI+LA

OTHER

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

Group SNI+F

OTHER

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

Group SN

OTHER

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

Interventions

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

Group SN; Group SNI; Group SNI+F; Group SNI+LA

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults
• ASA I or II status
• Scheduled for trauma or orthopedic surgeries of lower leg in spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Croatian Society of Regional Anesthesia and Analgesia: lead

Study Sites (1)

University Hospital of Traumatology

Zagreb, 10000, Croatia

Location

Related Publications (3)

• 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.

  PMID: 19471833 RESULT

• 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.

  PMID: 14609894 RESULT

• 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.

  PMID: 12708207 RESULT

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 7, 2010
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-06

Locations

CR (1)