Trial Outcomes & Findings for A Real-Time Ultrasound Guided Approach For Spinal Anesthesia (NCT NCT01570491)

NCT ID: NCT01570491

Last Updated: 2019-07-26

Results Overview

Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 10-15 minutes before the surgery
• Results posted on: 2019-07-26

Participant Flow

patients were recruited and enrolled from 4/2012 to 10/2012 at Cleveland clinic, main campus.

Participant milestones

Measure	Ultrasound-guided Spinal Anesthesia Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block.	Standard Spinal Anesthesia Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block.
Overall Study STARTED	19	19
Overall Study COMPLETED	14	18
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Measure	Ultrasound-guided Spinal Anesthesia Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block.	Standard Spinal Anesthesia Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block.
Overall Study Lost to Follow-up	3	1
Overall Study treatment: not given or discontinued	2	0

Baseline Characteristics

A Real-Time Ultrasound Guided Approach For Spinal Anesthesia

Baseline characteristics by cohort

Measure	Ultrasound-guided Spinal Anesthesia n=14 Participants Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block.	Standard Spinal Anesthesia n=18 Participants Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block.	Total n=32 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 10 • n=93 Participants	70 years STANDARD_DEVIATION 10 • n=4 Participants	70 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	9 Participants n=4 Participants	13 Participants n=27 Participants

PRIMARY outcome

Timeframe: 10-15 minutes before the surgery

Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery

Outcome measures

Measure	Ultrasound-guided Spinal Anesthesia n=14 Participants Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block.	Standard Spinal Anesthesia n=18 Participants Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block.
Number of Attempts	1 Attempts Interval 1.0 to 2.0	1 Attempts Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 10-15 minutes before the surgery

Difficulty of insertion, was rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult)

Outcome measures

Measure	Ultrasound-guided Spinal Anesthesia n=14 Participants Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block.	Standard Spinal Anesthesia n=18 Participants Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block.
Difficulty of Block Insertion	5.5 units on a scale Interval 4.0 to 7.0	2.5 units on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: after insert the block but before the surgery

Record patient satisfaction on a five-point Likert scale, where a value of 1 indicates extremely unsatisfied and a value of 5 indicates extremely satisfied.

Outcome measures

Measure	Ultrasound-guided Spinal Anesthesia n=14 Participants Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block.	Standard Spinal Anesthesia n=18 Participants Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block.
Patient Satisfaction	5 units on a scale Interval 4.0 to 5.0	5 units on a scale Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: as measured in seconds after needle insertion, surgical date

Time to perform block (from first needle insertion to injection of medication)

Outcome measures

Measure	Ultrasound-guided Spinal Anesthesia n=14 Participants Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block.	Standard Spinal Anesthesia n=18 Participants Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block.
Time to Perform Block (Second)	117.5 second Interval 67.0 to 247.0	256 second Interval 144.0 to 327.0

Adverse Events

Ultrasound-guided Spinal Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Spinal Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Sessler, MD

Cleveland Clinic

Phone: 2164444900

Email: sessled@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place