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Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?

Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion of Labour Epidural Catheters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00996905
Enrollment
128
Registered
2009-10-16
Start date
2009-10-31
Completion date
2010-10-31
Last updated
2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Epidural Analgesia, Ultrasound, Training, Inservice

Brief summary

Ultrasound scanning of the back has been shown to increase success when used to guide epidural catheter insertion. However, this technique is not applied widely in clinical practice. Stronger evidence is required to prove that it will improve the clinical experience of labour epidurals. The study hypothesis is that anesthesiologists (both residents and fellows), will have an increased rate of success and ease of insertion of labour epidural catheters, and that there will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done prior to the procedure.

Detailed description

Studies have shown that ultrasound scanning of the lumbar spine is beneficial in certain circumstances (eg. predicted difficult epidurals). However, no large scale studies with multiple anesthesiologists performing the technique have been done to show that ultrasound scanning may be of benefit in their everyday clinical practice. This study will involve residents and fellows, each performing epidural insertions with and without the use of ultrasound scanning of the lumbar spine prior to the procedure. If the hypothesis is correct, then the use of this technique may become widespread, resulting in less complications and increased patients satisfaction.

Interventions

DEVICEPortable ultrasound machine

Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

For Patients: Inclusion Criteria: * ability to Speak in English * requesting epidural analgesia for labour * having easily palpable spine (clinically 'easy' back)

Exclusion criteria

* contraindications to epidural analgesia * patients with a history of difficult epidural insertions or spinal anesthetic * Patients with a known history of back surgery * patients with known significant kyph0scoliosis For Anesthesiologists: Inclusion Criteria: * Residents and fellows training or practicing at Mount Sinai hospital and enrolled in either a residency or fellowship program at the University of Toronto.

Design outcomes

Primary

MeasureTime frame
Ease of epidural insertion by the following 3 measurements: time to perform procedure (minutes), number of levels at which insertion is attempted, and number of ventral passes of the epidural needle.20 minutes

Secondary

MeasureTime frame
The occurrence of inadvertent dural punctures.24-48 hours
Number of attempts to thread the epidural catheter20 minutes
Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)2 hours
The need of the anesthesiologist to call for assistance with the procedure30 minutes
Patient satisfaction as determine by a questionnaire24 hours and 1 week

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026