分娩鎮痛の有効性と安全性に対する超音波リアルタイム誘導技術の効果

実験的：硬膜穿刺硬膜外グループと組み合わせた超音波リアルタイム ガイダンス

超音波リアルタイムガイダンスと硬膜穿刺硬膜外治療を組み合わせることで、分娩鎮痛の臨床効果を向上させることができます。

デバイス：超音波リアルタイムガイダンスと硬膜穿刺硬膜外分娩鎮痛を組み合わせた

超音波リアルタイムガイダンス技術は、操作の視覚化による椎間腔位置決めの精度、成功率、穿刺損傷の軽減の点で、従来のブラインド探査技術に比べて大きな利点があり、脊椎ブロックの有効性と安全性を大幅に向上させます。

アクティブコンパレータ：硬膜穿刺硬膜外グループ

硬膜穿刺硬膜外穿刺は、脊髄硬膜外併用療法を臨床的に改良したもので、母体に広く使用されています。 実施手順は、硬膜外穿刺を完了し、一時的にチューブを留置せず、くも膜下麻酔針で硬膜を穿刺しますが、くも膜下腔に直接薬剤を注入せず、硬膜外ブロックに従って投与するために硬膜外カテーテルを残します。 。

デバイス：硬膜穿刺 硬膜外分娩鎮痛

硬膜穿刺硬膜外穿刺は、脊髄硬膜外併用療法を臨床的に改良したもので、母体に広く使用されています。 実施手順は、硬膜外穿刺を完了し、一時的にチューブを留置せず、くも膜下麻酔針で硬膜を穿刺しますが、くも膜下腔に直接薬剤を注入せず、硬膜外ブロックに従って投与するために硬膜外カテーテルを残します。 。

Composite endpoint of labor analgesia outcome

The primary outcome is a binary composite endpoint: "satisfactory" (Grades I-II) versus "unsatisfactory" (Grades III-IV). Grading followed a hierarchical rule (IV > III > II > I): if more than one grade applied, the highest (worst) was assigned.

Grade I (best): vaginal delivery (spontaneous or instrumental) with analgesic onset ≤ 20 min, mean VAS ≤ 40 mm, no catheter or protocol adjustment, and modified Bromage score < 2.

Grade II (good): vaginal delivery not meeting Grade I criteria but with onset ≤ 30 min, mean VAS ≤ 60 mm, and no Grade IV-listed complications.

Grade III (poor): cesarean delivery, or onset > 30 min, or mean VAS > 60 mm.

Grade IV (worst): serious analgesia-related complications (unintended dural puncture with the epidural needle, Bromage score ≥ 2, persistent neurological injury, local anesthetic toxicity, or severe hypotension requiring intervention).

Time to analgesia onset

Time from initial drug administration to the first documented Visual Analogue Scale (VAS) score ≤ 30 mm. VAS scale: 0 = no pain, 100 mm = worst possible pain.

Visual Analogue Scale (VAS) score

Time-weighted mean pain VAS score from analgesia start to delivery, derived from area under the curve (AUC) calculation. VAS scale: 0 = no pain, 100 mm = worst possible pain.

Number of patient-controlled analgesia (PCA) demands

Number of PCA bolus demands during labor analgesia.

Local anesthetic consumption

Per-minute local anesthetic consumption during labor analgesia.

Sensory blockade level

Sensory blockade level assessed by loss of cold sensation using an alcohol swab, recorded at 30 min after the loading dose and at the highest level.

Incidence of asymmetric block

Defined as a ≥ 2-dermatome difference in sensory blockade level between the left and right sides.

Sensory blockade at the second sacral dermatome (S2)

S2 sensory blockade categorized as bilateral, unilateral, or none.

Number of Participants with Physician Interventions

Physician interventions including analgesic regimen adjustments, epidural catheter repositioning, and re-puncture.

Modified Bromage score

Motor blockade assessed by the modified Bromage score: 0 = full flexion of knees and ankles, 1 = partial flexion of knees with full flexion of ankles, 2 = inability to flex knees with partial flexion of ankles, 3 = inability to flex knees and ankles.

Side effects of labor analgesia

Incidence of lower limb numbness (defined as loss of cold sensation by alcohol swab test), urinary retention (defined as inability to void spontaneously within 8 h postpartum requiring catheterization), nausea and vomiting, and postpartum headache.

Cesarean delivery rate and indications

Rate of cesarean delivery and indications for cesarean delivery (non-reassuring fetal heart rate, arrest of descent, maternal indications, other).

Mean uterine contraction frequency

Time-weighted mean uterine contraction frequency, derived from area under the curve (AUC) calculation from analgesia to delivery. Unit of measure: contractions per 10 minutes

Mean single uterine contraction duration

Time-weighted mean single uterine contraction duration, derived from area under the curve (AUC) calculation from analgesia to delivery. Unit of measure: seconds.

Incidence of uterine hypertonia

Defined as a single contraction lasting > 2 min.

Incidence of uterine tachysystole

Defined as > 5 contractions per 10 min.

Duration of each stage of labor

Duration of the first, second, third, and total stages of labor.

Maternal body temperature

Maternal body temperature before analgesia and at delivery.

NICHD fetal heart rate tracing classification

NICHD (National Institute of Child Health and Human Development) Fetal Heart Tracing Classification: Category I (normal), Category II (indeterminate), Category III (abnormal). A higher category indicates a less reassuring fetal status.

NICHD category progression rate

Proportion of parturients whose NICHD category worsened from baseline during labor analgesia.

Fetal heart rate

Time-weighted mean fetal heart rate from analgesia to delivery, derived from area under the curve (AUC) calculation.

Fetal heart rate decelerations

Types of fetal heart rate decelerations (early, late, variable).

Fetal heart rate variability

Fetal heart rate variability categorized as absent, minimal, moderate, or marked.

Neonatal Apgar scores

Apgar scores assessed at 1, 5, and 10 minutes after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better condition. The proportion of neonates with Apgar < 7 at 1 minute is also reported.

Post-delivery hs-CRP level

Post-delivery hs-CRP level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: mg/L.

Post-delivery IL-6 level

Post-delivery IL-6 level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: pg/mL.

Post-delivery cortisol level

Post-delivery cortisol level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: nmol/L.