Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2016
• Main ID: NCT02766829
• Date of registration: 06/05/2016
• Prospective Registration: No
• Primary sponsor: Indonesia University
• Public title: Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position
• Scientific title: Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position in Patients Underwent Urology Surgery
• Date of first enrolment: March 2015
• Target sample size: 211
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02766829
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Sidharta K Manggala, Consultant
• Affiliation: Indonesia University

Key inclusion & exclusion criteria

Inclusion Criteria:

- subjects aged 18-60 years old-

- subjects with ASA physical status I-III who were planned to undergo urology surgery
with spinal anesthesia

- Subjects who have been explained about the study, have agreed to enroll and have
signed the informed consent form

Exclusion Criteria:

- uncooperative subjects

- subjects with relative and absolute contraindications to spinal anesthesia
(coagulation disorders, thrombocytopenia, increases intracranial pressure, severe
hypovolemia, severe heart valve disorders, local infection at the injection site,
allergy toward local anesthetic agents, significant anatomical disorder of the spine,
wound/scar on the lumbal area)

- subjects with body mass index (BMI) > 32 kg/m2

Drop out criteria:

- subjects who requestes to drop out of the study

- subjects in need of emergency treatment during spinal anesthesia procedure

- subjects with more than nine times redirected spinal needle (failed spinal anesthesia
procedure).



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Adult Patients With Spinal Anesthesia

Intervention(s)

Procedure: Cross leg sitting position

Procedure: Traditional sitting position

Primary Outcome(s)

Needle-bone contact number [Time Frame: 7 months]

One shot successful spinal needle placement [Time Frame: 7 months]

The difficulty level of landmark palpation for injection [Time Frame: 7 months]

Secondary Outcome(s)

Spinal needle placement complications [Time Frame: 7 months]

Secondary ID(s)

IndonesiaUAnes007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors