Skip to main content
Clinical Trials/NCT02036242
NCT02036242CompletedPhase 4

Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control

Nanjing Medical University1 site in 1 country500 target enrollmentStarted: September 2013Last updated:
Conditions
Interventions
Drugs

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

Experimental

Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently

Intervention: Sole local anesthetic (Drug)

Sole local anesthetic

Experimental

Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently

Intervention: Ropivacaine (Drug)

Opioid plus local anesthetic

Active Comparator

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

Active Comparator

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

Sponsor
Nanjing Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fu Zhou Wang

Dr

Nanjing Medical University

Study Sites (1)

Loading locations...

Similar Trials

Sole Local Anesthetic Versus Opioid Plus... | Clinical Trial