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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Labor Analgesia

Intervention / Treatment
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* Device: handheld ultrasound-assisted technique
* Other: conventional palpation-guided technique


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handheld ultrasound-assisted technique<br>Participants will be received labor combined epidural-spinal analgesia using handheld ultrasound | Device: handheld ultrasound-assisted technique<br>* Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle.<br>|
| Active Comparator: Conventional palpation-guided technique<br>Participants will be received labor combined epidural-spinal analgesia using conventional landmark-guided technique | Other: conventional palpation-guided technique<br>* The interspinous space is detected by palpation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |