Ultrasound Versus Palpation for Spinal Anesthesia Success (Accuro)

T

Tel Aviv Sourasky Medical Center

Status

Completed

Conditions

Ultrasound

Treatments

Device: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03679663
TASMC-18-CFW-0219-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Palpation
No Intervention group
Description:
Anesthesia performed without ultrasound
Ultrasound
Experimental group
Description:
Anesthesia performed after ultrasound
Treatment:
Device: Ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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