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

Anesthesia Clinical Trial

Official title:

a Modified Method That Improved Residency Neuraxial Anesthesia Performance and Reduced Patient Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389672
• Other study ID #: IRB200812040R
• Status: Completed
• Phase: N/A
• First received: December 26, 2017
• Last updated: January 2, 2018
• Start date: January 1, 2011
• Est. completion date: September 30, 2012

Study information

• Verified date: January 2011
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: September 30, 2012
• Est. primary completion date: September 30, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia

Intervention

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
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	attempts	the number of skin-to-site needle punctures	at least three days
Secondary	complication	all types of complications, including a post dura-puncture headache epidural hematoma, infection, or any unexpected neurologic injury	at least three days