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A Trial on Ultrasound-assisted Spinal Anaesthesia

A Randomised Controlled Trial on Ultrasound-assisted Spinal Anaesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01699373
Enrollment
170
Registered
2012-10-03
Start date
2011-04-30
Completion date
2012-05-31
Last updated
2013-04-09

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

Conditions

Spinal Anaesthesia, Ultrasound

Brief summary

A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with manual palpation to identify landmarks for performance of spinal anaesthesia.

Interventions

PROCEDUREUltrasound scan

Pre-procedural ultrasound scan was performed

Sponsors

Changi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* ASA I to III * undergoing surgery amenable to spinal anaesthesia

Exclusion criteria

* Patient refusal * contraindications to regional anaesthesia * known allergy to local anaesthetics * bleeding diathesis * inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Success Rate of First-attempt of Spinal AnaesthesiaDuring procedure

Secondary

MeasureTime frame
Time Taken to Perform Spinal AnaesthesiaDuring procedure

Countries

Singapore

Participant flow

Recruitment details

April 2011-April 2012 Changi General Hospital

Participants by arm

ArmCount
Ultrasound-assisted
Pre-procedural ultrasound scan performed
85
Manual Palpation85
Total170

Baseline characteristics

CharacteristicManual PalpationUltrasound-assistedTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
85 Participants85 Participants170 Participants
Age Continuous63.7 years
STANDARD_DEVIATION 12.6
61.1 years
STANDARD_DEVIATION 13.3
62.4 years
STANDARD_DEVIATION 12.9
Region of Enrollment
Singapore
85 participants85 participants170 participants
Sex: Female, Male
Female
45 Participants30 Participants75 Participants
Sex: Female, Male
Male
40 Participants55 Participants95 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Success Rate of First-attempt of Spinal Anaesthesia

Time frame: During procedure

ArmMeasureValue (NUMBER)
Ultrasound-assistedSuccess Rate of First-attempt of Spinal Anaesthesia54 participants
Manual PalpationSuccess Rate of First-attempt of Spinal Anaesthesia44 participants
Secondary

Time Taken to Perform Spinal Anaesthesia

Time frame: During procedure

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026