Labor Analgesia
Conditions
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.
Interventions
DEVICEhandheld ultrasound-assisted technique
Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle.
OTHERconventional palpation-guided technique
The interspinous space is detected by palpation
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Success rate at the first attempt | During procedure | Success rate at the first attempt |
| 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 |
| 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) |
Countries
South Korea
Outcome results
None listed