Ultrasound Versus Palpation for Spinal Anesthesia Success

Ultrasound Clinical Trial

— Accuro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679663
• Other study ID #: TASMC-18-CFW-0219-CTIL
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: August 4, 2020

Study information

• Verified date: January 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 4, 2020
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Ultrasound

Intervention

Device:
• Ultrasound
Use of ultrasound to identify pre-puncture site

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The insertion site identification time,	time	10 mins
Secondary	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.	10 mins
Secondary	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