Epidural Analgesia on Electrophysiological Function
Condition: Prolonged Labor; Healthy; Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but whether
      it contributes to postpartum pelvic muscle disorder is unclear. This randomized controlled
      trial examined whether CSEA affects the electrophysiological index of postpartum pelvic floor
      muscle during labor. The investigators plan to recruit 300 primiparous healthy women.
    

Detailed description: 
      Labor analgesia can relieve labor pain, reduce stress reactions, and improve blood supply to
      the fetus, benefiting mother and baby. Though traditional epidural analgesia has been used
      for more than 40 years, combined spinal-epidural analgesia (CSEA) has become popular because
      it provides faster-onset pain relief with minimal motor weakness. CSEA may also accelerate
      cervical dilation.

      Despite the popularity of CSEA, whether it is associated with short- or long-term beneficial
      or adverse effects on mothers remains unclear. One question is whether the procedure affects
      the risk of female pelvic floor disorder (PFD), in which the pelvic floor muscles are
      injured. These muscles are responsible for supporting the pelvic organs and for stabilizing
      them during the rhythmic, strong labor contractions and for the diaphragm to contract enough
      to generate pressures of up to 19 kPa. Numerous risk factors have been associated with PFD,
      including obesity, diabetes, older age, connective tissue disorder, neurological disease,
      pregnancy, vaginal delivery and childbirth. PFD can lead in turn to stress urinary
      incontinence, overactive bladder, pelvic organ prolapse and fecal incontinence, all of which
      can strongly reduce women's physical and psychological health.

      Pelvic floor function can be analyzed by measuring the strength and degree of fatigue of
      pelvic floor muscles, as well as the pelvic dynamic pressure. Abnormalities in these
      indicators appear even before patients complain of the signs and symptoms of PFD, making them
      a useful early diagnostic index.

      In this randomized controlled study, we examined whether CSEA affects postpartum pelvic floor
      muscle function in primiparous mothers who give birth vaginally, as well as the duration of
      different stages of labor. Our results should help establish whether the widespread use of
      CSEA provides benefits to mothers or poses a risk.
    

Intervention name(s): CSEA (ropivocaine and sufentanil)
Intervention type(s): Drug
Intervention description(s): Women in the CSEA group received CSEA during labor. An intravenous line was established when the uterine opening measured 1-2 cm. Then sufentanil (5-7 μg) was injected intrathecally. When the visual analogue pain score was 3 or higher, a mixture of ropivocaine (0.143%) and sufentanil (0.3 μg/ml) was continuously infused into the epidural space using an analgesia pump until the cervix was fully dilated. Load capacity was 5 ml. The analgesic plane was controlled under T10.
Other intervention name(s): Combined spinal-epidural analgesia
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: combined spinal-epidural analgesia; pelvic floor muscle; postpartum electrophysiological function