The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
- Conditions
- Labor Analgesia
- Interventions
- Device: ultrasound real-time guidance combined with Epidural Labor AnagesiaDevice: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia
- Registration Number
- NCT05990504
- Lead Sponsor
- Zongxun Lin
- Brief Summary
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal.Dural Puncture Epidural Technique improves Labor Analgesia Quality And Safety By Increasing Drug Permeation.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.
- Detailed Description
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block. The theoretical basis is that anesthetic drugs can originally penetrate into the subarachnoid space from the epidural space through a complete spinal dura, and the puncture hole formed by spinal dura puncture facilitates this process.After injecting high volume anesthetic drugs into the epidural space, the pressure increases, and the drug penetrates from the epidural space through the puncture hole along a pressure gradient to the subarachnoid space, thereby enhancing the effect of labor analgesia.Dural Puncture Epidural also has the advantage of verifying that the epidural needle is in the middle of the epidural space again, thereby reducing the incidence of epidural catheter insertion failure or deviation to one side.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- American Society of Anesthesiologists (ASA) Class I or II;
- Single healthy pregnancy;
- Head showing first;
- 37 to 41 weeks;
- The labor process is active, and the cervix dilates<5cm;
- Require epidural labor analgesia;
- Volunteer to participate in this study and sign an informed consent form.
- Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes;
- Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction;
- Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture;
- Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate.
- Patients with long-term use of opioids, steroids, and chronic pain.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epidural Group ultrasound real-time guidance combined with Epidural Labor Anagesia Epidural is a traditional labor analgesia technique. Dural Puncture Epidural Group ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia Dural Puncture Epidural is a new type of labor analgesia technology.
- Primary Outcome Measures
Name Time Method Fetal heart indicators（Fetal heart rate） 7 weeks Assess fetal heart（Fetal heart rate）
Analgesic effect（block level） 7 weeks block level of pregnant women by Alcohol swab（temperature sensation：Pubic symphysis=T12，umbilical region=T10，hypochondrium=T8，xiphoid process=T6，Nipple connection=T4，subclavian=T2）
Analgesic effect（Patient controlled analgesia） 7 weeks number and time of Patient controlled analgesia（Press the PCA button when the patient feels pain）
Uterine contraction indicators（Number of pregnant women with hypertonus） 7 weeks hypertonus=Each Uterine contraction lasts for more than 2 minutes
Uterine contraction indicators（Number of pregnant women with Tachysystole） 7 weeks Tachysystole=More than 5 Uterine contraction in 10 minutes
Apgar score 7 weeks Apgar score（scale title=Apgar score，Total score=0-10，0-3=severe asphyxia，4-7=mild asphyxia，8-10=normal）
Analgesic effect（block effect） 7 weeks block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
Analgesic effect（Visual Analogue Scale） 7 weeks Analgesic effect of pregnant women by Visual Analogue Scale（scale title=Visual Analogue Scale，Total score=0-10,0=no pain,10=worst possible pain）
Uterine contraction indicators（duration） 7 weeks Assess uterine contractions（duration）
Sacral sensory block of pregnant women 7 weeks Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block））
modified bromage score 7 weeks modified bromage score（scale title=modified bromage score，Total score=0-3，0=no Motor nerve block; 1=unable to lift straight legs, but able to bend knees and move feet; 2=unable to lift straight legs or bend knees, but able to move feet; 3=unable to bend ankles, feet, or knees (completely blocked)）
Analgesic effect（onset time） 7 weeks Analgesic effect of pregnant women（onset time）
Fetal heart indicators（Fetal Heart Rate Variability） 7 weeks Assess fetal heart（Fetal Heart Rate Variability）
Uterine contraction indicators（Frequency） 7 weeks Assess uterine contractions（Frequency）
Fetal heart indicators（NICHD classification） 7 weeks Assess fetal heart（NICHD classification）
Fetal heart indicators（Fetal Heart Rate decelerations） 7 weeks Assess fetal heart（Fetal Heart Rate decelerations）
- Secondary Outcome Measures
Name Time Method Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale） 7 weeks Edinburgh Postnatal Depression Scale（scale title=Edinburgh Postnatal Depression Scale，Total score=0-30，≥13=Postpartum depression）
Number of pregnant women and reason with conversion of natural labor to Caesarean section 7 weeks Reasons for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)
Delivery satisfaction survey 7 weeks Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)
Delivery mode 7 weeks natural labor/cesarean section/instrument
body temperature changes 7 weeks body temperature changes
Side effects and complications of labor analgesia 7 weeks Side effects and complications of labor analgesia
Operation evaluation（Time） 7 weeks Assessment of puncture condition（Time）
Operation evaluation（number of times） 7 weeks Assessment of puncture condition（number of times）
Concentration of cortisol 7 weeks Pregnant women's venous blood cortisol
Maternal rehabilitation indicators（Postpartum hospital stay） 7 weeks Postpartum hospitalization days
Drug consumption 7 weeks Drug consumption
Effect of stages of labor（time） 7 weeks Effect of stages of labor（time）
Number of pregnant women with Infection during labor 7 weeks whether Infection during labor of pregnant women
Operation evaluation（side effects and Complications） 7 weeks Assessment of puncture condition（side effects and Complications）
Concentration of Interleukin 6 7 weeks Pregnant women's venous blood Interleukin 6
Self-Rating Anxiety Scale 7 weeks Self-Rating Anxiety Scale（scale title=Self-Rating Anxiety Scale，Total score=0-80，≥50=Anxiety）
Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40）） 7 weeks Postoperative Recovery Quality Scale（QOR-40）（scale title=Postoperative Recovery Quality Scale（QOR-40），Total score=0-200，The higher the score the better the recovery）
Number of pregnant women with adjust the treatment plan and adjustment method 7 weeks adjustment method include Adjust the Epidural catheter or Adjusting drug dosage
Delivery fear score（numerical rating scale） 7 weeks Delivery fear score by numerical rating scale（scale title=numerical rating scale，Total score=0-10，≥6=Delivery fear）
Concentration of hypersensitive C-reactive protein 7 weeks Pregnant women's venous blood hypersensitive C-reactive protein
Trial Locations
- Locations (1)
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China