NCT03389672

Brief 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. We hypothesized that a modified neuraxial anesthesia method would improve both residency training and patient safety.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
518

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2012

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
Last Updated

January 3, 2018

Status Verified

January 1, 2011

Enrollment Period

1.7 years

First QC Date

December 26, 2017

Last Update Submit

January 2, 2018

Conditions

Anesthesia

Keywords

patient safetyresidency training

Outcome Measures

Primary Outcomes (1)

  • attempts

    the number of skin-to-site needle punctures

    at least three days

Secondary Outcomes (1)

  • complication

    at least three days

Study Arms (3)

spinal anesthesia

The anesthesia technique were applied with modified approach and conventional approach

Procedure: spinal anesthesia

epidural anesthesia

The anesthesia technique were applied with modified approach and conventional approach

Procedure: epidural anesthesia

combined spinal-epidural anesthesia

The anesthesia technique were applied with modified approach and conventional approach

Procedure: combined spinal-epidural anesthesia

Interventions

spinal anesthesiaPROCEDURE

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.

spinal anesthesia
epidural anesthesiaPROCEDURE

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.

epidural anesthesia
combined spinal-epidural anesthesiaPROCEDURE

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.

combined spinal-epidural anesthesia

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparturients who were elective for cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • parturients who were elective for cesarean section

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 28802600BACKGROUND

  • de 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.

    PMID: 12145063BACKGROUND

  • Martin 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.

    PMID: 12401637BACKGROUND

  • Sahin 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.

    PMID: 24141882BACKGROUND

  • Shaikh 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.

    PMID: 23532866BACKGROUND

  • Perlas 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.

    PMID: 25493689BACKGROUND

  • Vallejo 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.

    PMID: 20696564BACKGROUND

  • Chen 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.

    PMID: 32615968DERIVED

MeSH Terms

Interventions

Anesthesia, SpinalAnesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Hong-Nerng Ho, PhD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 3, 2018

Study Start

January 1, 2011

Primary Completion

September 30, 2012

Study Completion

September 30, 2012

Last Updated

January 3, 2018

Record last verified: 2011-01