Clinical trial NCT03389672: Modified Paramedian Versus Conventional Technique in the Residency Training: An Observational Study
Official title: a Modified Method That Improved Residency Neuraxial Anesthesia Performance and Reduced Patient Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: patient safety
residency training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 518
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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)

Primary outcomes:
measure: attempts
timeFrame: at least three days
Secondary outcomes:
measure: complication
timeFrame: at least three days
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Hong-Nerng Ho, PhD
role: STUDY_CHAIR
References:
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citation: 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.