AnesthesiaNCT03389672
Modified Paramedian Versus Conventional Technique in the Residency Training: An Observational Study
An observational study of Anesthesia, run by National Taiwan University Hospital.
Trial summary
Residency training includes positive and negative aspects. Well-trained doctors must be educated, but the process may bring additional risks to patients. Anesthesiologists' performance when conducting neuraxial anesthesia is related to their experience. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- spinal anesthesia, epidural anesthesia and combined spinal-epidural anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 518 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 30 Sep 2012
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All parturients received regional anesthesia in the decubitus position, and the procedures were performed in the L3-4 or L4-5 interspace. For the conventional method, the injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For the modified method, the injection site was 0.5 cm lateral and 0.5 cm caudal to the spinous process, and the process was the same as the conventional method
Who may be able to join
- parturients who were elective for cesarean section
Who cannot join
- history of allergy to the medications used in this study
- chronic or acute headaches
- possible conversion to general anesthesia
- other contraindications to practice (infection, coagulopathy, abnormal spinal anatomy, unstable vital signs, and refusal to participate in the study)
About this study
Official title: a Modified Method That Improved Residency Neuraxial Anesthesia Performance and Reduced Patient Complications
Residency training includes positive and negative aspects. Well-trained doctors must be educated, but the process may bring additional risks to patients. Anesthesiologists' performance when conducting neuraxial anesthesia is related to their experience. We hypothesized that a modified neuraxial anesthesia method would improve both residency training and patient safety.
Read the detailed description
Residency training is performed using trial and error. Several studies have shown that the training process, practice period, and resident's attitude are important factors for determining performance. During the training process, neuraxial anesthesia safety is related to the operator's experience. Ultrasound can improve resident performance; however, using ultrasound technologies in well-established training programs may not be practical for all residencies.
The paramedian approach bypasses most of the bony structures that may impede the advancement of an epidural needle in the midline approach. However, the paramedian approach requires a sharpened three-dimensional insight compared with the midline approach. We hypothesized that the higher the three-dimensional barrier, the higher the complications and number of puncture attempts. A modified paramedian approach may improve residency training and patient safety. The aim of this study was to investigate whether the modified method decreased practice attempts and patient complications.
- Conditions
- Anesthesia
- Being tested
- spinal anesthesia, epidural anesthesia, combined spinal-epidural anesthesia
- Keywords
- patient safety, residency training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
For conventional spinal anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions.
epidural anesthesiaProcedure or surgery
For conventional epidural anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions.
combined spinal-epidural anesthesiaProcedure or surgery
For conventional combined spinal-epidural anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions.
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia | The anesthesia technique were applied with modified approach and conventional approach Receives: Procedure: spinal anesthesia | |
| epidural anesthesia | The anesthesia technique were applied with modified approach and conventional approach Receives: Procedure: epidural anesthesia | |
| combined spinal-epidural anesthesia | The anesthesia technique were applied with modified approach and conventional approach Receives: Procedure: combined spinal-epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
attempts
the number of skin-to-site needle punctures
Measured: at least three days
Secondary outcomes (1)
complication
all types of complications, including a post dura-puncture headache epidural hematoma, infection, or any unexpected neurologic injury
Measured: at least three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Jan 2011
- Primary completion30 Sep 2012
- Study completion30 Sep 2012
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong-Nerng Ho, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389672
- Sponsor's protocol ID
- IRB200812040R
- Status last verified
- Jan 2011
- First submitted
- 26 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request
Publications
Ambardekar AP. Selecting anesthesiology residency candidates-Beyond the numbers. J Clin Anesth. 2017 Sep;41:38-39. doi: 10.1016/j.jclinane.2017.05.006. No abstract available.
PubMed 28802600de Oliveira Filho GR. The construction of learning curves for basic skills in anesthetic procedures: an application for the cumulative sum method. Anesth Analg. 2002 Aug;95(2):411-6, table of contents. doi: 10.1097/00000539-200208000-00033.
PubMed 12145063Martin G, Lineberger CK, MacLeod DB, El-Moalem HE, Breslin DS, Hardman D, D'Ercole F. A new teaching model for resident training in regional anesthesia. Anesth Analg. 2002 Nov;95(5):1423-7, table of contents. doi: 10.1097/00000539-200211000-00059.
PubMed 12401637Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
PubMed 24141882Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720.
PubMed 23532866Perlas A, Chaparro LE, Chin KJ. Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):251-60. doi: 10.1097/AAP.0000000000000184.
PubMed 25493689Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
PubMed 20696564Chen SH, Chen SS, Lai CL, Su FY, Tzeng IS, Chen LK. Modified paramedian versus conventional paramedian technique in the residency training: an observational study. BMC Med Educ. 2020 Jul 2;20(1):211. doi: 10.1186/s12909-020-02118-0.
PubMed 32615968
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Modified Method That Improved Residency Neuraxial Anesthesia Performance and Reduced Patient Complications
- ClinicalTrials.gov ID
- NCT03389672
- Acronym / sponsor ID
- IRB200812040R
- Conditions
- Anesthesia
- Keywords
- patient safety, residency training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Sep 2012 (actual)
- Study completion
- 30 Sep 2012 (actual)
- First posted
- 3 Jan 2018 (actual)
- 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.
Residency training includes positive and negative aspects. Well-trained doctors must be educated, but the process may bring additional risks to patients. Anesthesiologists' performance when conducting neuraxial anesthesia is related to their experience. We hypothesized that a modified neuraxial anesthesia method would improve both residency training and patient safety.
Detailed description
Residency training is performed using trial and error. Several studies have shown that the training process, practice period, and resident's attitude are important factors for determining performance. During the training process, neuraxial anesthesia safety is related to the operator's experience. Ultrasound can improve resident performance; however, using ultrasound technologies in well-established training programs may not be practical for all residencies.
The paramedian approach bypasses most of the bony structures that may impede the advancement of an epidural needle in the midline approach. However, the paramedian approach requires a sharpened three-dimensional insight compared with the midline approach. We hypothesized that the higher the three-dimensional barrier, the higher the complications and number of puncture attempts. A modified paramedian approach may improve residency training and patient safety. The aim of this study was to investigate whether the modified method decreased practice attempts and patient complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia | – | Procedure: spinal anesthesiaThe anesthesia technique were applied with modified approach and conventional approach |
| epidural anesthesia | – | Procedure: epidural anesthesiaThe anesthesia technique were applied with modified approach and conventional approach |
| combined spinal-epidural anesthesia | – | Procedure: combined spinal-epidural anesthesiaThe anesthesia technique were applied with modified approach and conventional approach |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All parturients received regional anesthesia in the decubitus position, and the procedures were performed in the L3-4 or L4-5 interspace. For the conventional method, the injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For the modified method, the injection site was 0.5 cm lateral and 0.5 cm caudal to the spinous process, and the process was the same as the conventional method
Key inclusion criteria (1 listed)
- parturients who were elective for cesarean section
Key exclusion criteria (4 listed)
- history of allergy to the medications used in this study
- chronic or acute headaches
- possible conversion to general anesthesia
- other contraindications to practice (infection, coagulopathy, abnormal spinal anatomy, unstable vital signs, and refusal to participate in the study)
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 |
|---|---|---|
| spinal anesthesiaFor conventional spinal anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions. | Procedure or surgery | spinal anesthesia |
| epidural anesthesiaFor conventional epidural anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions. | Procedure or surgery | epidural anesthesia |
| combined spinal-epidural anesthesiaFor conventional combined spinal-epidural anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions. | Procedure or surgery | combined spinal-epidural anesthesia |
Primary outcome
attempts
Time frame: at least three days
the number of skin-to-site needle punctures
1 secondary outcome
complication
Time frame: at least three days
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 3 Jan 2018.
- Background: PubMed 28802600Ambardekar AP. Selecting anesthesiology residency candidates-Beyond the numbers. J Clin Anesth. 2017 Sep;41:38-39. doi: 10.1016/j.jclinane.2017.05.006. No abstract available.
- Background: PubMed 12145063de Oliveira Filho GR. The construction of learning curves for basic skills in anesthetic procedures: an application for the cumulative sum method. Anesth Analg. 2002 Aug;95(2):411-6, table of contents. doi: 10.1097/00000539-200208000-00033.
- Background: PubMed 12401637Martin G, Lineberger CK, MacLeod DB, El-Moalem HE, Breslin DS, Hardman D, D'Ercole F. A new teaching model for resident training in regional anesthesia. Anesth Analg. 2002 Nov;95(5):1423-7, table of contents. doi: 10.1097/00000539-200211000-00059.
- Background: PubMed 24141882Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
- Background: PubMed 23532866Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720.
- Background: PubMed 25493689Perlas A, Chaparro LE, Chin KJ. Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):251-60. doi: 10.1097/AAP.0000000000000184.
- Background: PubMed 20696564Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
- Derived from this study: PubMed 32615968Chen SH, Chen SS, Lai CL, Su FY, Tzeng IS, Chen LK. Modified paramedian versus conventional paramedian technique in the residency training: an observational study. BMC Med Educ. 2020 Jul 2;20(1):211. doi: 10.1186/s12909-020-02118-0.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request
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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.
Hong-Nerng Ho, PhD study chair
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by National Taiwan University Hospital.
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 1 inclusion and 4 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 3 Jan 2018. 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?
attempts (time frame: at least three days). 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 NCT03389672, 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 3 Jan 2018.