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

January 2, 2018 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

518

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
attempts
Time Frame: at least three days
the number of skin-to-site needle punctures
at least three days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at least three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Hong-Nerng Ho, PhD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

September 30, 2012

Study Completion (ACTUAL)

September 30, 2012

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (ACTUAL)

January 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB200812040R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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