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Modified Paramedian Versus Conventional Technique in the Residency Training: An Observational Study

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ClinicalTrials.gov Identifier: NCT03389672
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment
Anesthesia Procedure: spinal anesthesia Procedure: epidural anesthesia Procedure: combined spinal-epidural anesthesia

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 Type : Observational
Actual Enrollment : 518 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: a Modified Method That Improved Residency Neuraxial Anesthesia Performance and Reduced Patient Complications
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : September 30, 2012
Actual Study Completion Date : September 30, 2012

Group/Cohort Intervention/treatment
spinal anesthesia
The anesthesia technique were applied with modified approach and conventional approach
Procedure: spinal anesthesia
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 anesthesia
The anesthesia technique were applied with modified approach and conventional approach
Procedure: epidural anesthesia
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 anesthesia
The anesthesia technique were applied with modified approach and conventional approach
Procedure: combined spinal-epidural anesthesia
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.




Primary Outcome Measures :
  1. attempts [ Time Frame: at least three days ]
    the number of skin-to-site needle punctures


Secondary Outcome Measures :
  1. complication [ Time Frame: at least three days ]
    all types of complications, including a post dura-puncture headache epidural hematoma, infection, or any unexpected neurologic injury



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   parturients who were elective for cesarean section
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • parturients who were elective for cesarean section

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389672


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Hong-Nerng Ho, PhD National Taiwan University Hospital

Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03389672     History of Changes
Other Study ID Numbers: IRB200812040R
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
patient safety
residency training

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs