Pregnancy, Caesarean SectionNCT02753660
Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia
A study testing Traditional sitting position and Pendant position in people with Pregnancy, Caesarean Section, run by Universitas Indonesia.
Trial summary
The aim of this study was to compare the successful spinal puncture among patients with pendant position in comparison with those who used traditional sitting position for caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Caesarean Section
- What is being tested?
- Traditional sitting position and Pendant position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women aged 18-45 years old
- Body Mass Index (BMI) 18-35 kg/m2
- physical status American Society of Anesthesiologists (ASA) I-III
- planned to undergo cesarean section with spinal anesthesia and signed the informed consent form
Who cannot join
- Patients with any contraindication for spinal anesthesia (infection on injection site, coagulation disorder, severe hypovolemia, increased intracranial pressure, aortic and/or mitral stenosis)
- pregnancy with head entrapment of the fetus, umbilical cord prolapse, feet presentation,
- Patient with eclampsia
- Patient with cardiovascular diseases
- Patient with scoliosis
- Patient with history of lumbar surgery
Show all 9Show fewer
- Patient with unpalpable intervertebral space due to thick fatty tissue or edema.
- Drop out criteria:
- spinal block was failed or only partial block
About this study
Official title: Comparison Between Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia for Cesarean Section
The aim of this study was to compare the successful spinal puncture among patients with pendant position in comparison with those who used traditional sitting position for caesarean section.
Read the detailed description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were divided into Group A for traditional sitting position (n=154) and Group B for pendant position (n=154). The outcome parameters recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and the duration to perform spinal puncture. Data were analyzed by using Statistical Package for Social Scientist (SPSS) version 21.0. Numerical data was served in median with minimal and maximal value. Numerical data was analyzed by using Mann-Whitney test. Categorical data was served by using relative risk (RR) with 95% confidence interval (95% CI) and was analyzed by using Chi-Square test.
- Conditions
- Pregnancy, Caesarean Section
- Being tested
- Traditional sitting position, Pendant position
- Keywords
- spinal, anesthesia, pendant, spinal-bone contact, puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional sitting positionProcedure or surgery
Subjects were set on traditional sitting position before spinal anesthesia begun.
Pendant positionProcedure or surgery
Subjects were set on pendant position before spinal anesthesia begun.
| Study group | Role | What they receive |
|---|---|---|
| Traditional sitting position | Active comparator | Patient is positioned with her knees flexed 90o, both feet hanging of the bed and propped up by a chair, both arms hugging a pillow, adducted pelvic, maximum pelvic flexion were done to create maximal sagittal lumbal flexion before spinal anesthesia begun. Receives: Procedure: Traditional sitting position |
| Pendant position | Experimental | Patients sit with both their underarms propped up on a metal prop, thus both arms hanging from the prop before spinal anesthesia begun. Receives: Procedure: Pendant position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful spinal puncture attempt number
The number of attempt for the successful spinal puncture for each positions
Measured: 2 months
The number of spinal needle-bone contact
The number of spinal needle-bone contact for each positions
Measured: 2 months
Spinal puncture duration
the duration to perform spinal puncture for each positions
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, Caesarean SectionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pryambodho Pryambodho, Universitas Indonesia
- Investigators
- Pryambodho Pryambodho, Consultant, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753660
- Sponsor's protocol ID
- IndonesiaUAnes001
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
Publications
de Filho GR, Gomes HP, da Fonseca MH, Hoffman JC, Pederneiras SG, Garcia JH. Predictors of successful neuraxial block: a prospective study. Eur J Anaesthesiol. 2002 Jun;19(6):447-51. doi: 10.1017/s0265021502000716.
PubMed 12094920Fisher KS, Arnholt AT, Douglas ME, Vandiver SL, Nguyen DH. A randomized trial of the traditional sitting position versus the hamstring stretch position for labor epidural needle placement. Anesth Analg. 2009 Aug;109(2):532-4. doi: 10.1213/ane.0b013e3181ac6c79.
PubMed 19608828Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.
PubMed 24790901Shabanian G, Saadat M. A position for administration of difficult spinal anesthesia. J Clin Diagn Res. 2014 Mar;8(3):190-1. doi: 10.7860/JCDR/2014/5881.4198. Epub 2014 Mar 15. No abstract available.
PubMed 24783134Grau T, Leipold RW, Horter J, Conradi R, Martin E, Motsch J. The lumbar epidural space in pregnancy: visualization by ultrasonography. Br J Anaesth. 2001 Jun;86(6):798-804. doi: 10.1093/bja/86.6.798.
PubMed 11573586Tekeoglu I, Adak B, Bozkurt M, Gurbuzoglu N. Distraction of lumbar vertebrae in gravitational traction. Spine (Phila Pa 1976). 1998 May 1;23(9):1061-3; discussion 1064. doi: 10.1097/00007632-199805010-00019.
PubMed 9589547Shankar H, Rajput K, Murugiah K. Correlation between spinous process dimensions and ease of spinal anaesthesia. Indian J Anaesth. 2012 May;56(3):250-4. doi: 10.4103/0019-5049.98769.
PubMed 22923823Brooks RR, Oudekerk C, Olson RL, Daniel C, Vacchiano C, Maye J. The effect of spinal introducer needle use on postoperative back pain. AANA J. 2002 Dec;70(6):449-52.
PubMed 12526150
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT02753660
- Acronym / sponsor ID
- IndonesiaUAnes001
- Conditions
- Pregnancy, Caesarean Section
- Keywords
- spinal, anesthesia, pendant, spinal-bone contact, puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to compare the successful spinal puncture among patients with pendant position in comparison with those who used traditional sitting position for caesarean section.
Detailed description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were divided into Group A for traditional sitting position (n=154) and Group B for pendant position (n=154). The outcome parameters recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and the duration to perform spinal puncture. Data were analyzed by using Statistical Package for Social Scientist (SPSS) version 21.0. Numerical data was served in median with minimal and maximal value. Numerical data was analyzed by using Mann-Whitney test. Categorical data was served by using relative risk (RR) with 95% confidence interval (95% CI) and was analyzed by using Chi-Square test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional sitting position | Active comparator | Procedure: Traditional sitting positionPatient is positioned with her knees flexed 90o, both feet hanging of the bed and propped up by a chair, both arms hugging a pillow, adducted pelvic, maximum pelvic flexion were done to create maximal sagittal lumbal flexion before spinal anesthesia begun. |
| Pendant position | Experimental | Procedure: Pendant positionPatients sit with both their underarms propped up on a metal prop, thus both arms hanging from the prop before spinal anesthesia begun. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- pregnant women aged 18-45 years old
- Body Mass Index (BMI) 18-35 kg/m2
- physical status American Society of Anesthesiologists (ASA) I-III
- planned to undergo cesarean section with spinal anesthesia and signed the informed consent form
Key exclusion criteria (9 listed)
- Patients with any contraindication for spinal anesthesia (infection on injection site, coagulation disorder, severe hypovolemia, increased intracranial pressure, aortic and/or mitral stenosis)
- pregnancy with head entrapment of the fetus, umbilical cord prolapse, feet presentation,
- Patient with eclampsia
- Patient with cardiovascular diseases
- Patient with scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional sitting positionSubjects were set on traditional sitting position before spinal anesthesia begun. | Procedure or surgery | Traditional sitting position |
| Pendant positionSubjects were set on pendant position before spinal anesthesia begun. | Procedure or surgery | Pendant position |
Primary outcome
Successful spinal puncture attempt number
Time frame: 2 months
The number of attempt for the successful spinal puncture for each positions
The number of spinal needle-bone contact
Time frame: 2 months
The number of spinal needle-bone contact for each positions
Spinal puncture duration
Time frame: 2 months
the duration to perform spinal puncture for each positions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Background: PubMed 12094920de Filho GR, Gomes HP, da Fonseca MH, Hoffman JC, Pederneiras SG, Garcia JH. Predictors of successful neuraxial block: a prospective study. Eur J Anaesthesiol. 2002 Jun;19(6):447-51. doi: 10.1017/s0265021502000716.
- Background: PubMed 19608828Fisher KS, Arnholt AT, Douglas ME, Vandiver SL, Nguyen DH. A randomized trial of the traditional sitting position versus the hamstring stretch position for labor epidural needle placement. Anesth Analg. 2009 Aug;109(2):532-4. doi: 10.1213/ane.0b013e3181ac6c79.
- Background: PubMed 24790901Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.
- Background: PubMed 24783134Shabanian G, Saadat M. A position for administration of difficult spinal anesthesia. J Clin Diagn Res. 2014 Mar;8(3):190-1. doi: 10.7860/JCDR/2014/5881.4198. Epub 2014 Mar 15. No abstract available.
- Background: PubMed 11573586Grau T, Leipold RW, Horter J, Conradi R, Martin E, Motsch J. The lumbar epidural space in pregnancy: visualization by ultrasonography. Br J Anaesth. 2001 Jun;86(6):798-804. doi: 10.1093/bja/86.6.798.
- Background: PubMed 9589547Tekeoglu I, Adak B, Bozkurt M, Gurbuzoglu N. Distraction of lumbar vertebrae in gravitational traction. Spine (Phila Pa 1976). 1998 May 1;23(9):1061-3; discussion 1064. doi: 10.1097/00007632-199805010-00019.
- Background: PubMed 22923823Shankar H, Rajput K, Murugiah K. Correlation between spinous process dimensions and ease of spinal anaesthesia. Indian J Anaesth. 2012 May;56(3):250-4. doi: 10.4103/0019-5049.98769.
- Background: PubMed 12526150Brooks RR, Oudekerk C, Olson RL, Daniel C, Vacchiano C, Maye J. The effect of spinal introducer needle use on postoperative back pain. AANA J. 2002 Dec;70(6):449-52.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pryambodho Pryambodho, Consultant principal investigator
Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A study testing Traditional sitting position and Pendant position in people with Pregnancy, Caesarean Section, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful spinal puncture attempt number (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753660, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.