Trials / Completed
CompletedNCT03679663
Ultrasound Versus Palpation for Spinal Anesthesia Success
Prospective Randomized Controlled Trial to Compare a Handheld Ultrasound Identification of the Neuraxial Block Insertion Site Versus Palpation Only in an Obese Population of Women Undergoing Cesarean Delivery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Tel-Aviv Sourasky Medical Center · Other Government
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ultrasound | Use of ultrasound to identify pre-puncture site |
Timeline
- Start date
- 2018-12-20
- Primary completion
- 2020-08-04
- Completion
- 2020-08-04
- First posted
- 2018-09-20
- Last updated
- 2020-10-05
Locations
1 site across 1 country: Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03679663. Inclusion in this directory is not an endorsement.