Clinical trial NCT02036242: Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia
Official title: Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Opioid
Local anesthetic
Labor delivery
Safety
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.


Eligibility criteria: Inclusion Criteria:

* Nulliparas
* Request epidural analgesia
* Chinese

Exclusion Criteria:

* Allergic to opioid or local anesthetics
* Fail to perform epidural puncture and catheterization
* Organ dysfunction
* Contraindications for epidural anesthesia

Primary outcomes:
measure: Pain scorings
timeFrame: up to 3 days
Secondary outcomes:
measure: Pruritus
timeFrame: From post-randomization to post-delivery day 3
measure: Dizziness
timeFrame: From post-randomization to post-delivery day 3
measure: Nausea
timeFrame: From post-randomization to post-delivery day 3
measure: Vomiting
timeFrame: From post-randomization to post-delivery day 3
measure: Drowsiness
timeFrame: From post-randomization to post-delivery day 3
measure: Sedation
timeFrame: From post-randomization to post-delivery day 3
measure: Respiratory depression
timeFrame: From post-randomization to post-delivery day 3
measure: Psychological effects
timeFrame: From post-randomization to post-delivery day 3
measure: Myoclonus
timeFrame: From post-randomization to post-delivery day 3
measure: Maternal heart rate
timeFrame: From post-randomization to post-delivery day 3
measure: Miosis
timeFrame: From post-randomization to post-delivery day 3
measure: Cesarean section
timeFrame: The time at the end of the labor delivery
Other outcomes:
measure: Time to latent phase
timeFrame: From the beginning of regular contraction of uterus to the dilation of cervical 4cm
measure: Time of active phase
timeFrame: From the cervix 4cm to the dilation of cervical 10cm
measure: Overall satisfaction of analgesia
timeFrame: At the time of the end of the labor delivery
measure: Oxytocin usage
timeFrame: At the time of the end of the labor
measure: Neonatal Apgar score
timeFrame: At the time of the baby was born, 1min, 5min, 10min and 20min
measure: Instrumental delivery
timeFrame: At the time of the end of the labor
measure: Umbilical gas analysis
timeFrame: At the time of the fetus was delivery
Locations:
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
References:
citation: Wang X, Xu S, Qin X, Li X, Feng SW, Liu Y, Wang W, Guo X, Shen R, Shen X, Wang F. Comparison Between the Use of Ropivacaine Alone and Ropivacaine With Sufentanil in Epidural Labor Analgesia. Medicine (Baltimore). 2015 Oct;94(43):e1882. doi: 10.1097/MD.0000000000001882.