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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Handheld ultrasound-assisted technique | Experimental | Participants will be received labor combined epidural-spinal analgesia using handheld ultrasound |
|
| Conventional palpation-guided technique | Active Comparator | Participants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| handheld ultrasound-assisted technique | Device | Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of passes | Number of times the puncture needle was redirected without removing it from the skin | During procedure |
| Number of needle insertion attempts | Number of times the puncture needle was removed from the skin and reinserted |
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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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| Name | Affiliation | Role |
|---|---|---|
| Sun-Kyung Park, M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23076897 | Background | 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. | |
| 26695878 | Background | 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. |
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| conventional palpation-guided technique | Other | The interspinous space is detected by palpation |
|
| During procedure |
| Procedural duration | time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter | During procedure |
| Identifying time | time required to complete the preprocedural spinal ultrasound or the assessment by palpation | During procedure |
| Success rate at the first needle pass | Success rate at the first needle pass | During procedure |
| Success rate at the first attempt | Success rate at the first attempt | During procedure |
| Need to use alternative methods | Need to use alternative methods for success | During procedure |
| Number of interspace levels at which the insertion was attempted | Number of interspace levels at which the insertion was attempted | During procedure |
| Success rate of dural puncture with needle-through-needle technique | Success rate of dural puncture with needle-through-needle technique | During procedure |
| Incidence of radicular pain, paresthesia, and bloody tapping | Incidence of radicular pain, paresthesia, and bloody tapping during the procedure | During 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) | During procedure |
| 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 |
| Depth by ultrasound | Depth to the ligamentum flavum-dura mater complex (LFD) as determined by ultrasound | During procedure |
| Actual needle depth (cm) | Depth of the needle when the epidural space and dural space are found (cm) | During procedure |
| 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 |
| 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 |
| Incidence of inadvertent dural puncture | Incidence of inadvertent dural puncture | During procedure |
| Incidence of postdural puncture headache | Incidence of postdural puncture headache | Up to 2 weeks |
| 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 |
| 25493689 | Background | 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. |
| 33329842 | Background | 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. |
| 31880632 | Background | 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. |
| 31188153 | Background | 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. |
| 31690644 | Background | 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. |
| 27183373 | Background | 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. |
| 29322504 | Background | 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. |
| 25036283 | Background | 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. |
| 38155223 | Derived | Bae J, Kim Y, Yoo S, Kim JT, Park SK. Handheld ultrasound-assisted versus palpation-guided combined spinal-epidural for labor analgesia: a randomized controlled trial. Sci Rep. 2023 Dec 27;13(1):23009. doi: 10.1038/s41598-023-50407-7. |