Transient hip and knee flexion for rapid onset spinal anaesthesia (ROSA) for caesarean section, a randomised control study

Transient hip and knee flexion for rapid onset spinal anaesthesia (ROSA) for women undergoing elective caesarean section, a randomised control study to evaluate the time from completing spinal injection until the anaesthetist determines surgery can proceed and surgery commences.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000893606

Acronym

ROSA

Enrollment

Registered

2014-08-22

Start date

2014-09-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The aim of this study is to assess whether, following a spinal anaesthetic for caesarean, transient maternal hip and knee flexion in the left lateral tilt supine position can allow caesarean section to commence earlier than traditional positioning with lower limbs straight. If this technique safely speeds up the onset of "adequate" surgical block suitable for the caesarean operation, it can potentially reduce the rate of caesarean sections requiring general anaesthetics. It is well established that in pregnant women requiring caesarean section most of the anaesthesia related risks have higher rate under general anaesthesia in comparison to spinal anaesthesia.

Interventions

Immediately after finishing intrathecal injection, patients in the control group will be laid supine with a 10-15 degree tilt to the left and their lower limbs straight. The drug and dose of intrathecal injection will remain the choice of the anaesthetist and will not be controlled in this study. Patients in the intervention group will be laid supine with a 10-15 degree tilt to the left and their lower limbs flexed at the hips and knees maintained for 45 seconds before straightening them as per the control group. Note that if patient cannot tolerate the positioning, the manoeuvre is to be discontinued immediately and anaesthesia positioning will be continued with the patient's lower limbs straight as per the control group. Measurement and documentation of the block height will take place every 3 minutes post intrathecal injection using ice to test cold sensation in the anterior axillary line

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Parturients having elective lower segment caesarean section under spinal anaesthesia >18 years

Exclusion criteria

Women <18 years old Women requiring an interpreter when one is unavailable Women with an intellectual or mental impairment Women with pre-existing medical, rheumatologic or orthopaedic conditions which prevents them from performing the manoeuvre correctly e.g. recent lower limb fracture, ankylosing spondylitis.

Outcome results