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

Adult Patients With Spinal Anesthesia Clinical Trial

Official title:

Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position in Patients Underwent Urology Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766829
• Other study ID #: IndonesiaUAnes007
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: May 9, 2016
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The study aimed to compare successful spinal needle placement between crossed leg sitting position and traditional sitting position in patients underwent urology surgery.

Description:

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were randomly divided into CLSP Group for crossed leg sitting position (n=105) and TSP Group for traditional sitting position (n=106). Non-invasive blood pressure (NIBP) monitor, eletrocardiography (ECG), oxygen nasal cannula and pulse-oxymetry was set on the subjects in the operation room. Baseline information was recorded. Spinal anesthesia was done by anesthesiology registrars that have done 50 spinal anesthesia procedures and have been explained about the protocol of spinal anesthesia injection in this study (to avoid bias). Outcome measures were the number of successful spinal needle placement in the first attempt, the difficulty level of landmark palpation for injection, and the number of needle-bone contact. Data was analyzed by SPSS (Statistical Package for Social Scientist) using Chi-Square test, Fisher Exact test, and Kolmogorov-Smirnov test. Significance value used was 5% with 80% power.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adult Patients With Spinal Anesthesia

Intervention

Procedure:
• Cross leg sitting position
Subjects were set on cross leg sitting position before spinal anesthesia begun.
• Traditional sitting position
Subjects were set on traditional sitting position before spinal anesthesia begun.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One shot successful spinal needle placement	The number of successful spinal needle placement in the first attempt	7 months	No
Primary	Needle-bone contact number	The number of needle-bone contact recorded.	7 months	No
Primary	The difficulty level of landmark palpation for injection	the difficulty level of landmark palpation for injection were assessed as easy or difficult.	7 months	No
Secondary	Spinal needle placement complications	Complications recorded were post dural puncture headache, low back pain and neural trauma.	7 months	No