This trial is active, not recruiting.

Conditions patients aged 55 or older, bmi more than 40 kg/m2, scoliosis
Treatments ultrasound guided placement spinal block, standard spinal anesthesia
Sponsor The Cleveland Clinic
Start date March 2012
End date January 2017
Trial size 40 participants
Trial identifier NCT01570491, 11-1171


No sample size estimation methodology currently exists for the right-censored count data models. We expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total. Patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique. A block randomization scheme with random block sizes ranging from 2-8 patients will be used. The outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. The post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block. The analysis will be conducted by a statistician who will be blinded.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
(Active Comparator)
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.
(Placebo Comparator)
Anesthesiologist will use standard spinal anesthesia insertion technique for block placement.
standard spinal anesthesia
Anesthesiologist will use standard technique for placement of spinal block.

Primary Outcomes

number of block attempts
time frame: counting, day one

Secondary Outcomes

insertion depth of needle
time frame: as measured in mm
compare anatomical landmark target to ultrasound guided target for needle placement
time frame: as measured in minutes before needle insertion, Day one
difficulty of block insertion
time frame: as reported seconds after block insertion, Day one
block failure rate
time frame: counting, Day one
Patient satisfaction
time frame: as reported minutes after injection of medication, Day one
Incidence of PDPH (post dural puncture headache)
time frame: self report minutes after injection of medication, Day one
time to perform block
time frame: as measured in seconds after needle insertion, Day one
tip of needle visibility
time frame: Day One

Eligibility Criteria

Male or female participants at least 55 years old.

Inclusion Criteria: - Patients aged 55 or older - BMI more than 40 - Scoliosis Exclusion criterion: - Patients who have undergone previous Spine Surgery

Additional Information

Principal investigator Hesham Elsharkawy, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.