Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Handheld ultrasound-assisted technique Participants will be received labor combined epidural-spinal analgesia using handheld ultrasound |
Device: handheld ultrasound-assisted technique
Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle.
|
| Active Comparator: Conventional palpation-guided technique Participants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique |
Other: conventional palpation-guided technique
The interspinous space is detected by palpation
|
Outcome Measures
Primary Outcome Measures
- Total duration of combined spinal-epidural procedure [During 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 [During procedure]
Number of times the puncture needle was redirected without removing it from the skin
- Number of needle insertion attempts [During procedure]
Number of times the puncture needle was removed from the skin and reinserted
- Procedural duration [During procedure]
time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter
- Identifying time [During procedure]
time required to complete the preprocedural spinal ultrasound or the assessment by palpation
- Success rate at the first needle pass [During procedure]
Success rate at the first needle pass
- Success rate at the first attempt [During procedure]
Success rate at the first attempt
- Need to use alternative methods [During procedure]
Need to use alternative methods for success
- Number of interspace levels at which the insertion was attempted [During procedure]
Number of interspace levels at which the insertion was attempted
- Success rate of dural puncture with needle-through-needle technique [During procedure]
Success rate of dural puncture with needle-through-needle technique
- Incidence of radicular pain, paresthesia, and bloody tapping [During procedure]
Incidence of radicular pain, paresthesia, and bloody tapping during the procedure
- Procedural pain using 11-point verbal rating scale [During procedure]
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 [During procedure]
Degree of discomfort during the procedure using 11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
- Depth by ultrasound [During procedure]
Depth to the ligamentum flavum-dura mater complex (LFD) as determined by ultrasound
- Actual needle depth (cm) [During procedure]
Depth of the needle when the epidural space and dural space are found (cm)
- Failure of labor analgesia [Within 2 hours after the procedure]
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 [From the end of the procedure to delivery]
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 [During procedure]
Incidence of inadvertent dural puncture
- Incidence of postdural puncture headache [Up to 2 weeks]
Incidence of postdural puncture headache
- Incidence of back pain postpartum at the site of epidural insertion [Up to 2 weeks]
Incidence of back pain postpartum at the site of epidural insertion
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult parturients with ASA physical status classification I, II or III requiring a combined spinal-epidural for labor analgesia
Exclusion Criteria:
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Contraindication to neuraxial anesthesia (local anesthetics hypersensitivity, coagulopathy, needle insertion site infection, etc.)
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Difficulty in communication
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Severe cardiac disease
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History of spine surgery
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Anatomical abnormality of the lumbar spine
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Age under 18
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Sun-Kyung Park, M.D., Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2101-016-1186