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

Primary Purpose

Labor Analgesia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
handheld ultrasound-assisted technique
conventional palpation-guided technique
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Handheld ultrasound-assisted technique

Conventional palpation-guided technique

Arm Description

Participants will be received labor combined epidural-spinal analgesia using handheld ultrasound

Participants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of passes
Number of times the puncture needle was redirected without removing it from the skin
Number of needle insertion attempts
Number of times the puncture needle was removed from the skin and reinserted
Procedural duration
time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter
Identifying time
time required to complete the preprocedural spinal ultrasound or the assessment by palpation
Success rate at the first needle pass
Success rate at the first needle pass
Success rate at the first attempt
Success rate at the first attempt
Need to use alternative methods
Need to use alternative methods for success
Number of interspace levels at which the insertion was attempted
Number of interspace levels at which the insertion was attempted
Success rate of dural puncture with needle-through-needle technique
Success rate of dural puncture with needle-through-needle technique
Incidence of radicular pain, paresthesia, and bloody tapping
Incidence of radicular pain, paresthesia, and bloody tapping during the procedure
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)
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)
Depth by ultrasound
Depth to the ligamentum flavum-dura mater complex (LFD) as determined by ultrasound
Actual needle depth (cm)
Depth of the needle when the epidural space and dural space are found (cm)
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
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)
Incidence of inadvertent dural puncture
Incidence of inadvertent dural puncture
Incidence of postdural puncture headache
Incidence of postdural puncture headache
Incidence of back pain postpartum at the site of epidural insertion
Incidence of back pain postpartum at the site of epidural insertion

Full Information

First Posted
February 8, 2021
Last Updated
October 25, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04759547
Brief Title
Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia
Official Title
Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
December 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Handheld ultrasound-assisted technique
Arm Type
Experimental
Arm Description
Participants will be received labor combined epidural-spinal analgesia using handheld ultrasound
Arm Title
Conventional palpation-guided technique
Arm Type
Active Comparator
Arm Description
Participants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique
Intervention Type
Device
Intervention Name(s)
handheld ultrasound-assisted technique
Intervention Description
Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle.
Intervention Type
Other
Intervention Name(s)
conventional palpation-guided technique
Intervention Description
The interspinous space is detected by palpation
Primary Outcome Measure Information:
Title
Total duration of combined spinal-epidural procedure
Description
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)
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Number of passes
Description
Number of times the puncture needle was redirected without removing it from the skin
Time Frame
During procedure
Title
Number of needle insertion attempts
Description
Number of times the puncture needle was removed from the skin and reinserted
Time Frame
During procedure
Title
Procedural duration
Description
time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter
Time Frame
During procedure
Title
Identifying time
Description
time required to complete the preprocedural spinal ultrasound or the assessment by palpation
Time Frame
During procedure
Title
Success rate at the first needle pass
Description
Success rate at the first needle pass
Time Frame
During procedure
Title
Success rate at the first attempt
Description
Success rate at the first attempt
Time Frame
During procedure
Title
Need to use alternative methods
Description
Need to use alternative methods for success
Time Frame
During procedure
Title
Number of interspace levels at which the insertion was attempted
Description
Number of interspace levels at which the insertion was attempted
Time Frame
During procedure
Title
Success rate of dural puncture with needle-through-needle technique
Description
Success rate of dural puncture with needle-through-needle technique
Time Frame
During procedure
Title
Incidence of radicular pain, paresthesia, and bloody tapping
Description
Incidence of radicular pain, paresthesia, and bloody tapping during the procedure
Time Frame
During procedure
Title
Procedural pain using 11-point verbal rating scale
Description
Degree of pain during the procedure using 11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Time Frame
During procedure
Title
Procedural discomfort using 11-point verbal rating scale
Description
Degree of discomfort during the procedure using 11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Time Frame
During procedure
Title
Depth by ultrasound
Description
Depth to the ligamentum flavum-dura mater complex (LFD) as determined by ultrasound
Time Frame
During procedure
Title
Actual needle depth (cm)
Description
Depth of the needle when the epidural space and dural space are found (cm)
Time Frame
During procedure
Title
Failure of labor analgesia
Description
The need to reinsert a new epidural catheter due to lack of sufficient analgesia within 2 hours of the primary insertion
Time Frame
Within 2 hours after the procedure
Title
Patient satisfaction using 11-point verbal rating scale
Description
Patient satisfaction with the quality of labor analgesia using 11-point verbal rating scale (0=very unsatisfied, 10=very satisfied)
Time Frame
From the end of the procedure to delivery
Title
Incidence of inadvertent dural puncture
Description
Incidence of inadvertent dural puncture
Time Frame
During procedure
Title
Incidence of postdural puncture headache
Description
Incidence of postdural puncture headache
Time Frame
Up to 2 weeks
Title
Incidence of back pain postpartum at the site of epidural insertion
Description
Incidence of back pain postpartum at the site of epidural insertion
Time Frame
Up to 2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun-Kyung Park, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23076897
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(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.
Results Reference
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PubMed Identifier
26695878
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.
Results Reference
background
PubMed Identifier
25493689
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.
Results Reference
background
PubMed Identifier
33329842
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.
Results Reference
background
PubMed Identifier
31880632
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.
Results Reference
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PubMed Identifier
31188153
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.
Results Reference
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PubMed Identifier
31690644
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:rapm-2019-100980. doi: 10.1136/rapm-2019-100980. Online ahead of print.
Results Reference
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PubMed Identifier
27183373
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.
Results Reference
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PubMed Identifier
29322504
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.
Results Reference
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Citation
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.
Results Reference
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Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia

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