Trials / Completed
CompletedNCT01157247
Intravenous Fentanyl or Local Anesthetic Infiltration for Pain Reducing During Spinal Needle Insertion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Croatian Society of Regional Anesthesia and Analgesia · Academic / Other
- Sex
- All
- Age
- 35 Years – 55 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2010-06-01
- Completion
- 2010-07-01
- First posted
- 2010-07-07
- Last updated
- 2010-07-07
Locations
1 site across 1 country: Croatia
Source: ClinicalTrials.gov record NCT01157247. Inclusion in this directory is not an endorsement.