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

Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157247
• Other study ID #: CSRAA-CMA:007/03
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: July 6, 2010
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: June 2010
• Source: Croatian Society of Regional Anesthesia and Analgesia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 55 Years

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Spinal Puncture

Intervention

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

Locations

Country	Name	City	State
Croatia	University Hospital of Traumatology	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Croatian Society of Regional Anesthesia and Analgesia

Country where clinical trial is conducted

Croatia, 

References & 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. Portuguese. — View Citation

Calderón E, Pernia A, Román MD, Pérez 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. — View Citation

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. — View Citation