Ultrasound Versus Palpation for Spinal Anesthesia Success

Not Applicable

Completed

• Conditions: Ultrasound
• Interventions: Device: Ultrasound

• Registration Number: NCT03679663
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-20
• Study Start: 2018-12-20
• Status Verified: 2020-01
• Primary Completion: 2020-08-04
• Study Completion: 2020-08-04
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound	Anesthesia performed after ultrasound

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel