Ultrasound Versus Palpation for Spinal Anesthesia Success

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2020-08-04

Brief Summary

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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.

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Detailed Description

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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

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Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Palpation

Anesthesia performed without ultrasound

Group Type NO_INTERVENTION

No interventions assigned to this group

Ultrasound

Anesthesia performed after ultrasound

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Use of ultrasound to identify pre-puncture site

Interventions

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Ultrasound

Use of ultrasound to identify pre-puncture site

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No