An interventional study of Sensory block level check using ice in Labor Pain, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Not applicable, Interventional, and Prevention
Assessment of the upper sensory block level during neuraxial analgesia for labor and delivery is an essential component of clinical management and patient safety. A variety of methods have been used for testing the sensory block such as cold, light touch, sharp touch or prick and transcutaneous electrical stimulation. In addition to the diversity of methods, the endpoints used by investigators have also been variable, considering total or partial responses as endpoints. Not surprisingly, a variable sensory block level could be identified as a result of the different methods and types of question asked by the examiner. Another complicating factor is the lack of standardization of the direction of the testing as it relates to anesthetized and non-anesthetized areas. This lack of standardization may result in a difference of several dermatomes in the level that two different assessors might record for the same patient. Considering a clinical research scenario, it may be difficult to replicate results and implement clinical practices. The objective of this study is to determine the degree of agreement between two methods of assessing the sensory block level to cold in women receiving epidural analgesia for labor (anesthetized to non-anesthetized segments versus non-anesthetized to anesthetized segments).
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 326 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 135 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Sensory block level check using ice, moving from cephalad to caudal
Diagnostic Test: Sensory block level check using ice
Sensory block level check using ice, moving from caudal to cephalad
Diagnostic Test: Sensory block level check using ice
Patients are asked to report when the ice feels as cold as it does on the forehead.
The lower sensory block level to cold
The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold
Time frame: 1 hour
The upper sensory block level to cold
The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold
Time frame: 1 hour
Patient satisfaction
Patients will be asked to report satisfaction with the test done from 0-10 (0=very uncomfortable 10=most comfortable
Time frame: 20 minutes
The lower sensory block level to cold
The sensory block level will be defined as: the dermatome at which and below which there is complete loss of sensation to cold
Time frame: 2 hours
The upper sensory block level to cold
The sensory block level will be defined as: the dermatome at which and below which there is still partial sensation to cold
Time frame: 2 hours
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Samuel Lunenfeld Research Institute, Mount Sinai Hospital