Clinical trial NCT04759547: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Analgesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Total duration of combined spinal-epidural procedure
timeFrame: During procedure
Secondary outcomes:
measure: Number of passes
timeFrame: During procedure
measure: Number of needle insertion attempts
timeFrame: During procedure
measure: Procedural duration
timeFrame: During procedure
measure: Identifying time
timeFrame: During procedure
measure: Success rate at the first needle pass
timeFrame: During procedure
measure: Success rate at the first attempt
timeFrame: During procedure
measure: Need to use alternative methods
timeFrame: During procedure
measure: Number of interspace levels at which the insertion was attempted
timeFrame: During procedure
measure: Success rate of dural puncture with needle-through-needle technique
timeFrame: During procedure
measure: Incidence of radicular pain, paresthesia, and bloody tapping
timeFrame: During procedure
measure: Procedural pain using 11-point verbal rating scale
timeFrame: During procedure
measure: Procedural discomfort using 11-point verbal rating scale
timeFrame: During procedure
measure: Depth by ultrasound
timeFrame: During procedure
measure: Actual needle depth (cm)
timeFrame: During procedure
measure: Failure of labor analgesia
timeFrame: Within 2 hours after the procedure
measure: Patient satisfaction using 11-point verbal rating scale
timeFrame: From the end of the procedure to delivery
measure: Incidence of inadvertent dural puncture
timeFrame: During procedure
measure: Incidence of postdural puncture headache
timeFrame: Up to 2 weeks
measure: Incidence of back pain postpartum at the site of epidural insertion
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sun-Kyung Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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.
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.
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.
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.
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.