An interventional study of Ultrasound in Ultrasound, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-05.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Diagnostic
Aim is to investigate the difference in number of attempts to place neuraxial block comparing handheld ultrasound versus use of palpation alone for women with impalpable bony landmarks undergoing spinal anesthesia for elective cesarean delivery.
Patients will be recruited prior to cesarean delivery and their site of lumbar injection will be examined. Women with impalpable bony landmarks will be offered recruitment to the study. Women will be randomly assigned to the standard of care group - palpation attempts only, versus an ultrasound group, where the insertion point will be identified by the handheld ultrasound device
Inclusion criteria:
Lumbar spinous processes impalpable. Elective cesarean delivery for singleton pregnancies BMI >30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned Exclusion Criteria Refuses informed consent Poor written Hebrew, no spoken English or Hebrew Patients will be randomized into two groups : an ultrasound (US) group and a palpation (PP) group.
The primary outcome of our study is the number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted.
Secondary outcomes include:
The insertion site identification time, patient verbal numerical pain score (0-10) after skin incision.
Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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Inclusion Criteria:
Lumbar spinous processes impalpable. Elective caesarean delivery for singleton pregnancies BMI >30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned
Anesthesia performed without ultrasound
Anesthesia performed after ultrasound
Device: Ultrasound
Use of ultrasound to identify pre-puncture site
Needle movement
number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted.
Time frame: 10 mins
The insertion site identification time,
time
Time frame: 10 mins
Patient verbal numerical pain score (0-10) after skin incision.
Patient verbal numerical pain score (0-10) after skin incision. Scale is Verbal numerical rating scale, where zero = no pain at all and 10 = maximum possible pain.
Time frame: 10 mins
Patient verbal numerical pain score (0-10) after spinal performance. Patient verbal numerical pain score (0-10). Scale is Verbal numerical rating scale, where zero = no pain at all and 10 = maximum possible pain.
Patient verbal numerical pain score (0-10) after spinal performance. Patient verbal numerical pain score (0-10) Scale is Verbal numerical rating scale, where zero = no pain at all and 10 = maximum possible pain.
Time frame: 10 mins
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center