A Real-Time Ultrasound Guided Approach For Spinal Anesthesia
|ClinicalTrials.gov Identifier: NCT01570491|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2012
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Patients Aged 55 or Older BMI More Than 40 kg/m2 Scoliosis||Other: ultrasound guided placement spinal block Other: standard spinal anesthesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
Active Comparator: ultrasound-guided spinal anesthesia
Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement.
Other: ultrasound guided placement spinal block
Anesthesiologist will use ultrasound as a guide for placement of spinal block.
Placebo Comparator: standard spinal anesthesia
Anesthesiologist will use standard spinal anesthesia insertion technique for block placement.
Other: standard spinal anesthesia
Anesthesiologist will use standard technique for placement of spinal block.
- number of block attempts [ Time Frame: counting, day one ]Real-time ultrasound guidance during spinal anesthesia reduces the number of attempts required for successful dural puncture.
- insertion depth of needle [ Time Frame: as measured in mm ]Agreement between actual needle insertion depth and the ultrasound-measured depth to the Dura.
- compare anatomical landmark target to ultrasound guided target for needle placement [ Time Frame: as measured in minutes before needle insertion, Day one ]Determine the correct level and compare the anatomical landmarks with the Ultrasound marks.
- difficulty of block insertion [ Time Frame: as reported seconds after block insertion, Day one ]Difficulty of insertion, using a 10 point scale
- block failure rate [ Time Frame: counting, Day one ]Calculate block failure rate
- Patient satisfaction [ Time Frame: as reported minutes after injection of medication, Day one ]Record patient satisfaction
- Incidence of PDPH (post dural puncture headache) [ Time Frame: self report minutes after injection of medication, Day one ]Incidence of PDPH (post dural puncture headache)
- time to perform block [ Time Frame: as measured in seconds after needle insertion, Day one ]Time to perform block (from first needle insertion to injection of medication)
- tip of needle visibility [ Time Frame: Day One ]Ability of the operator to visualize the tip of the needle with ultrasound
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570491
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Hesham Elsharkawy, M.D.||The Cleveland Clinic|