Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia

Labor Analgesia Clinical Trial

Official title:

Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759547
• Other study ID #: 2101-016-1186
• Status: Completed
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: December 25, 2021

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Parturients who need combined spinal-epidural analgesia for labour analgesia are randomly assigned to two groups. For the handheld ultrasound-assisted technique group, ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle. For the conventional palpation-guided technique group, the interspinous space is detected by palpation. Procedure time, the number of needle passes, the number of needle insertion attempts, success rate, and complications are compared.

Description:

This study aims to determine whether handheld ultrasound-guidance can reduce procedural time for labor combined spinal-epidural analgesia compared with conventional surface landmark-guided technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 25, 2021
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult parturients with ASA physical status classification I, II or III requiring a combined spinal-epidural for labor analgesia

Exclusion Criteria:

• Contraindication to neuraxial anesthesia (local anesthetics hypersensitivity, coagulopathy, needle insertion site infection, etc.)

• Difficulty in communication

• Severe cardiac disease

• History of spine surgery

• Anatomical abnormality of the lumbar spine

• Age under 18

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

Device:
• handheld ultrasound-assisted technique
Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle.

Other:
• conventional palpation-guided technique
The interspinous space is detected by palpation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119. — View Citation

Bae J, Park SK, Yoo S, Lim YJ, Kim JT. Influence of age, laterality, patient position, and spinal level on the interlamina space for spinal puncture. Reg Anesth Pain Med. 2019 Nov 4. pii: rapm-2019-100980. doi: 10.1136/rapm-2019-100980. [Epub ahead of print] — View Citation

Chin A, Crooke B, Heywood L, Brijball R, Pelecanos AM, Abeypala W. A randomised controlled trial comparing needle movements during combined spinal-epidural anaesthesia with and without ultrasound assistance. Anaesthesia. 2018 Apr;73(4):466-473. doi: 10.1111/anae.14206. Epub 2018 Jan 10. — View Citation

Neal JM, Brull R, Horn JL, Liu SS, McCartney CJ, Perlas A, Salinas FV, Tsui BC. The Second American Society of Regional Anesthesia and Pain Medicine Evidence-Based Medicine Assessment of Ultrasound-Guided Regional Anesthesia: Executive Summary. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):181-94. doi: 10.1097/AAP.0000000000000331. Review. — View Citation

Park SK, Bae J, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy: A Randomized Controlled Trial. Anesth Analg. 2020 Mar;130(3):787-795. doi: 10.1213/ANE.0000000000004600. — View Citation

Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029. — 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

Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003401. doi: 10.1002/14651858.CD003401.pub3. Review. — View Citation

Tawfik MM, Atallah MM, Elkharboutly WS, Allakkany NS, Abdelkhalek M. Does Preprocedural Ultrasound Increase the First-Pass Success Rate of Epidural Catheterization Before Cesarean Delivery? A Randomized Controlled Trial. Anesth Analg. 2017 Mar;124(3):851-856. doi: 10.1213/ANE.0000000000001325. — View Citation

Yoo S, Kim Y, Park SK, Ji SH, Kim JT. Ultrasonography for lumbar neuraxial block. Anesth Pain Med (Seoul). 2020 Oct 30;15(4):397-408. doi: 10.17085/apm.20065. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total duration of combined spinal-epidural procedure	Identifying time (time required to complete the preprocedural spinal ultrasound or the assessment by palpation) + Procedural duration (time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter)	During procedure
Secondary	Number of passes	Number of times the puncture needle was redirected without removing it from the skin	During procedure
Secondary	Number of needle insertion attempts	Number of times the puncture needle was removed from the skin and reinserted	During procedure
Secondary	Procedural duration	time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter	During procedure
Secondary	Identifying time	time required to complete the preprocedural spinal ultrasound or the assessment by palpation	During procedure
Secondary	Success rate at the first needle pass	Success rate at the first needle pass	During procedure
Secondary	Success rate at the first attempt	Success rate at the first attempt	During procedure
Secondary	Need to use alternative methods	Need to use alternative methods for success	During procedure
Secondary	Number of interspace levels at which the insertion was attempted	Number of interspace levels at which the insertion was attempted	During procedure
Secondary	Success rate of dural puncture with needle-through-needle technique	Success rate of dural puncture with needle-through-needle technique	During procedure
Secondary	Incidence of radicular pain, paresthesia, and bloody tapping	Incidence of radicular pain, paresthesia, and bloody tapping during the procedure	During procedure
Secondary	Procedural pain using 11-point verbal rating scale	Degree of pain during the procedure using 11-point verbal rating scale (0=no pain, 10=most pain imaginable)	During procedure
Secondary	Procedural discomfort using 11-point verbal rating scale	Degree of discomfort during the procedure using 11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)	During procedure
Secondary	Depth by ultrasound	Depth to the ligamentum flavum-dura mater complex (LFD) as determined by ultrasound	During procedure
Secondary	Actual needle depth (cm)	Depth of the needle when the epidural space and dural space are found (cm)	During procedure
Secondary	Failure of labor analgesia	The need to reinsert a new epidural catheter due to lack of sufficient analgesia within 2 hours of the primary insertion	Within 2 hours after the procedure
Secondary	Patient satisfaction using 11-point verbal rating scale	Patient satisfaction with the quality of labor analgesia using 11-point verbal rating scale (0=very unsatisfied, 10=very satisfied)	From the end of the procedure to delivery
Secondary	Incidence of inadvertent dural puncture	Incidence of inadvertent dural puncture	During procedure
Secondary	Incidence of postdural puncture headache	Incidence of postdural puncture headache	Up to 2 weeks
Secondary	Incidence of back pain postpartum at the site of epidural insertion	Incidence of back pain postpartum at the site of epidural insertion	Up to 2 weeks