Ultrasound
Conditions
Keywords
ultrasound
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUltrasound
Use of ultrasound to identify pre-puncture site
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
RCT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needle movement | 10 mins | number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The insertion site identification time, | 10 mins | time |
| Patient verbal numerical pain score (0-10) after skin incision. | 10 mins | 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. |
| 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 | 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. |
Countries
Israel
Outcome results
None listed