Adult Patients With Spinal AnesthesiaNCT02766829
Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position
A study testing Cross leg sitting position and Traditional sitting position in people with Adult Patients With Spinal Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Adult Patients With Spinal Anesthesia
- What is being tested?
- Cross leg sitting position and Traditional sitting position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteIndonesia
- Study dates
- Mar 2015to Oct 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position in Patients Underwent Urology Surgery
The study aimed to compare successful spinal needle placement between crossed leg sitting position and traditional sitting position in patients underwent urology surgery.
Read the detailed 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.
- Conditions
- Adult Patients With Spinal Anesthesia
- Being tested
- Cross leg sitting position, Traditional sitting position
- Keywords
- spinal, anesthesia, sitting, cross leg, spinal-bone contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross leg sitting positionProcedure or surgery
Subjects were set on cross leg sitting position before spinal anesthesia begun.
Traditional sitting positionProcedure or surgery
Subjects were set on traditional sitting position before spinal anesthesia begun.
| Study group | Role | What they receive |
|---|---|---|
| CLSP Group | Experimental | Those with cross leg sitting position: patients sit with both their knees flexed medially, hip flexed, resulting in pelvic leaning posteriorly and reducing lumbal lordosis. Receives: Procedure: Cross leg sitting position |
| TSP Group | Active comparator | Those with traditional sitting position: 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. Receives: Procedure: Traditional sitting position |
What is being measured
The primary outcome is the main question the study is designed to answer.
One shot successful spinal needle placement
The number of successful spinal needle placement in the first attempt
Measured: 7 months
Needle-bone contact number
The number of needle-bone contact recorded.
Measured: 7 months
The difficulty level of landmark palpation for injection
the difficulty level of landmark palpation for injection were assessed as easy or difficult.
Measured: 7 months
Secondary outcomes (1)
Spinal needle placement complications
Complications recorded were post dural puncture headache, low back pain and neural trauma.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Adult Patients With Spinal AnesthesiaStudies 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
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidharta K. Manggala, Universitas Indonesia
- Investigators
- Sidharta K Manggala, Consultant, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766829
- Sponsor's protocol ID
- IndonesiaUAnes007
- Status last verified
- May 2016
- First submitted
- 6 May 2016
- Last updated
- 10 May 2016
- Results posted
- No
Publications
Edwards ND, Callaghan LC, White T, Reilly CS. Perioperative myocardial ischaemia in patients undergoing transurethral surgery: a pilot study comparing general with spinal anaesthesia. Br J Anaesth. 1995 Apr;74(4):368-72. doi: 10.1093/bja/74.4.368.
PubMed 7734251Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.
PubMed 19420004Sprung J, Bourke DL, Grass J, Hammel J, Mascha E, Thomas P, Tubin I. Predicting the difficult neuraxial block: a prospective study. Anesth Analg. 1999 Aug;89(2):384-9. doi: 10.1097/00000539-199908000-00025.
PubMed 10439752Atallah MM, Demian AD, Shorrab AA. Development of a difficulty score for spinal anaesthesia. Br J Anaesth. 2004 Mar;92(3):354-60. doi: 10.1093/bja/aeh073. Epub 2004 Jan 22.
PubMed 14742333Kim JH, Song SY, Kim BJ. Predicting the difficulty in performing a neuraxial blockade. Korean J Anesthesiol. 2011 Nov;61(5):377-81. doi: 10.4097/kjae.2011.61.5.377. Epub 2011 Nov 23.
PubMed 22148085de 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 12094920Chin KJ, Karmakar MK, Peng P. Ultrasonography of the adult thoracic and lumbar spine for central neuraxial blockade. Anesthesiology. 2011 Jun;114(6):1459-85. doi: 10.1097/ALN.0b013e318210f9f8.
PubMed 21422997Fisher 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 24790901Watanabe S, Kobara K, Ishida H, Eguchi A. Influence of trunk muscle co-contraction on spinal curvature during sitting cross-legged. Electromyogr Clin Neurophysiol. 2010 Apr-Jun;50(3-4):187-92.
PubMed 20552952Biswas BK, Agarwal B, Bhattarai B, Dey S, Bhattacharyya P. Straight versus flex back: Does it matter in spinal anaesthesia? Indian J Anaesth. 2012 May;56(3):259-64. doi: 10.4103/0019-5049.98772.
PubMed 22923825Shankar 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 22923823Purepong N, Jitvimonrat A, Boonyong S, Thaveeratitham P, Pensri P. Effect of flexibility exercise on lumbar angle: a study among non-specific low back pain patients. J Bodyw Mov Ther. 2012 Apr;16(2):236-43. doi: 10.1016/j.jbmt.2011.08.001. Epub 2011 Aug 31.
PubMed 22464123Lin N, Li Y, Bebawy JF, Dong J, Hua L. Abdominal circumference but not the degree of lumbar flexion affects the accuracy of lumbar interspace identification by Tuffier's line palpation method: an observational study. BMC Anesthesiol. 2015 Jan 21;15:9. doi: 10.1186/1471-2253-15-9. eCollection 2015.
PubMed 25670920Kopacz DJ, Neal JM, Pollock JE. The regional anesthesia "learning curve". What is the minimum number of epidural and spinal blocks to reach consistency? Reg Anesth. 1996 May-Jun;21(3):182-90.
PubMed 8744658
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position in Patients Underwent Urology Surgery
- ClinicalTrials.gov ID
- NCT02766829
- Acronym / sponsor ID
- IndonesiaUAnes007
- Conditions
- Adult Patients With Spinal Anesthesia
- Keywords
- spinal, anesthesia, sitting, cross leg, spinal-bone contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 May 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 study aimed to compare successful spinal needle placement between crossed leg sitting position and traditional sitting position in patients underwent urology surgery.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLSP Group | Experimental | Procedure: Cross leg sitting positionThose with cross leg sitting position: patients sit with both their knees flexed medially, hip flexed, resulting in pelvic leaning posteriorly and reducing lumbal lordosis. |
| TSP Group | Active comparator | Procedure: Traditional sitting positionThose with traditional sitting position: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- subjects who requestes to drop out of the study
- subjects in need of emergency treatment during spinal anesthesia procedure
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 |
|---|---|---|
| Cross leg sitting positionSubjects were set on cross leg sitting position before spinal anesthesia begun. | Procedure or surgery | CLSP Group |
| Traditional sitting positionSubjects were set on traditional sitting position before spinal anesthesia begun. | Procedure or surgery | TSP Group |
Primary outcome
One shot successful spinal needle placement
Time frame: 7 months
The number of successful spinal needle placement in the first attempt
Needle-bone contact number
Time frame: 7 months
The number of needle-bone contact recorded.
The difficulty level of landmark palpation for injection
Time frame: 7 months
the difficulty level of landmark palpation for injection were assessed as easy or difficult.
1 secondary outcome
Spinal needle placement complications
Time frame: 7 months
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 10 May 2016.
- Background: PubMed 7734251Edwards ND, Callaghan LC, White T, Reilly CS. Perioperative myocardial ischaemia in patients undergoing transurethral surgery: a pilot study comparing general with spinal anaesthesia. Br J Anaesth. 1995 Apr;74(4):368-72. doi: 10.1093/bja/74.4.368.
- Background: PubMed 19420004Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.
- Background: PubMed 10439752Sprung J, Bourke DL, Grass J, Hammel J, Mascha E, Thomas P, Tubin I. Predicting the difficult neuraxial block: a prospective study. Anesth Analg. 1999 Aug;89(2):384-9. doi: 10.1097/00000539-199908000-00025.
- Background: PubMed 14742333Atallah MM, Demian AD, Shorrab AA. Development of a difficulty score for spinal anaesthesia. Br J Anaesth. 2004 Mar;92(3):354-60. doi: 10.1093/bja/aeh073. Epub 2004 Jan 22.
- Background: PubMed 22148085Kim JH, Song SY, Kim BJ. Predicting the difficulty in performing a neuraxial blockade. Korean J Anesthesiol. 2011 Nov;61(5):377-81. doi: 10.4097/kjae.2011.61.5.377. Epub 2011 Nov 23.
- 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 21422997Chin KJ, Karmakar MK, Peng P. Ultrasonography of the adult thoracic and lumbar spine for central neuraxial blockade. Anesthesiology. 2011 Jun;114(6):1459-85. doi: 10.1097/ALN.0b013e318210f9f8.
- 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 20552952Watanabe S, Kobara K, Ishida H, Eguchi A. Influence of trunk muscle co-contraction on spinal curvature during sitting cross-legged. Electromyogr Clin Neurophysiol. 2010 Apr-Jun;50(3-4):187-92.
- Background: PubMed 22923825Biswas BK, Agarwal B, Bhattarai B, Dey S, Bhattacharyya P. Straight versus flex back: Does it matter in spinal anaesthesia? Indian J Anaesth. 2012 May;56(3):259-64. doi: 10.4103/0019-5049.98772.
- 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.
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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.
Sidharta K Manggala, Consultant principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross leg sitting position and Traditional sitting position in people with Adult Patients With Spinal Anesthesia, run by Universitas Indonesia at 1 site in 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 3 inclusion and 7 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
One shot successful spinal needle placement (time frame: 7 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 NCT02766829, which also lists 24 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 10 May 2016.