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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palpation | No Intervention | Anesthesia performed without ultrasound | |
| Ultrasound | Experimental | Anesthesia performed after ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Use of ultrasound to identify pre-puncture site |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 mins |
| Measure | Description | Time Frame |
|---|---|---|
| The insertion site identification time, | time | 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. |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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RCT
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The outcomes will be assessed by an observer who was not in the room when the puncture site was identified and was blinded to the study group. The room set up will be identical with the handheld ultrasound placed visible in all cases, including those randomized to the palpation group.
| 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. | 10 mins |