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Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia (OLAA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fu Zhou Wang, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT02036242
First received: January 11, 2014
Last updated: February 1, 2014
Last verified: February 2014
  Purpose
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.

Condition Intervention Phase
Pain Drug: Sole local anesthetic Drug: Sufentanil (Opioid plus local anesthetic) Drug: Ropivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control

Resource links provided by NLM:


Further study details as provided by Fu Zhou Wang, Nanjing Medical University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Pruritus [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of pruritus 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 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.

  • Dizziness [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of dizziness 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 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.

  • Nausea [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of nausea 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 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.

  • Vomiting [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of vomiting 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 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.

  • Drowsiness [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of drowsiness 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 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.

  • Sedation [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of sedation 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 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.

  • Respiratory depression [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of respiratory depression 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 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.

  • Psychological effects [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of psychological effects [euphoria, hallucinations, delirium and confusion] 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 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.

  • Myoclonus [ Time Frame: From post-randomization to post-delivery day 3 ]

    This describes muscle rigidity and abnormal movement of the limbs and muscles.

    Record incidence of myoclonus 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 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.


  • Maternal heart rate [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of maternal heart rate 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 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.

  • Miosis [ Time Frame: From post-randomization to post-delivery day 3 ]
    Record incidence of miosis 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 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.

  • Cesarean section [ Time Frame: The time at the end of the labor delivery ]
    Record the incidence of Cesarean section after completion of the labor delivery.


Other Outcome Measures:
  • Time to latent phase [ Time Frame: From the beginning of regular contraction of uterus to the dilation of cervical 4cm ]
    Record the time duration

  • Time of active phase [ Time Frame: From the cervix 4cm to the dilation of cervical 10cm ]
    Record the time duration

  • Overall satisfaction of analgesia [ Time Frame: At the time of the end of the labor delivery ]
    Assess the analgesia satisfaction after the completion of the labor delivery

  • Oxytocin usage [ Time Frame: At the time of the end of the labor ]
    Record the total usage of oxytocin after completion of the labor delivery

  • Neonatal Apgar score [ Time Frame: At the time of the baby was born, 1min, 5min, 10min and 20min ]
  • Instrumental delivery [ Time Frame: At the time of the end of the labor ]
    Record the incidence of instrumental delivery after completion of the labor delivery.

  • Umbilical gas analysis [ Time Frame: At the time of the fetus was delivery ]

Enrollment: 500
Study Start Date: September 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
Drug: Sole local anesthetic
0.125% ropivacaine 10-15 ml every 1h during labor delivery
Other Names:
  • Ropivacaine
  • Naropin
Drug: Ropivacaine
Active Comparator: Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
Drug: Sufentanil (Opioid plus local anesthetic)
Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
Other Name: Naropin
Drug: Ropivacaine

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036242

Locations
China, Jiangsu
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fu Zhou Wang, Dr, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02036242     History of Changes
Other Study ID Numbers: NJFY13007
JQX12009 ( Other Grant/Funding Number: Nanjing Municipal Bureau of Health )
Study First Received: January 11, 2014
Last Updated: February 1, 2014

Keywords provided by Fu Zhou Wang, Nanjing Medical University:
Opioid
Local anesthetic
Labor delivery
Safety

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Sufentanil
Analgesics, Opioid
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on July 26, 2017