Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Pain scorings
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Nulliparas
- •Request epidural analgesia
Exclusion Criteria
- •Allergic to opioid or local anesthetics
- •Fail to perform epidural puncture and catheterization
- •Organ dysfunction
- •Contraindications for epidural anesthesia
Arms & Interventions
Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
Intervention: Sole local anesthetic (Drug)
Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
Intervention: Ropivacaine (Drug)
Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
Intervention: Sufentanil (Opioid plus local anesthetic) (Drug)
Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
Intervention: Ropivacaine (Drug)
Outcomes
Primary Outcomes
Pain scorings
Time Frame: up to 3 days
Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Secondary Outcomes
- Dizziness(From post-randomization to post-delivery day 3)
- Sedation(From post-randomization to post-delivery day 3)
- Respiratory depression(From post-randomization to post-delivery day 3)
- Pruritus(From post-randomization to post-delivery day 3)
- Nausea(From post-randomization to post-delivery day 3)
- Psychological effects(From post-randomization to post-delivery day 3)
- Myoclonus(From post-randomization to post-delivery day 3)
- Maternal heart rate(From post-randomization to post-delivery day 3)
- Miosis(From post-randomization to post-delivery day 3)
- Cesarean section(The time at the end of the labor delivery)
- Vomiting(From post-randomization to post-delivery day 3)
- Drowsiness(From post-randomization to post-delivery day 3)
Investigators
Fu Zhou Wang
Dr
Nanjing Medical University