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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Nanjing Medical University:

Primary Outcome Measures:
  • Pain scorings [ Time Frame: up to 3 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Record the time duration

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

  • Overall satisfaction of analgesia [ Time Frame: At the time of the end of the labor delivery ] [ Designated as safety issue: Yes ]
    Assess the analgesia satisfaction after the completion of the labor delivery

  • Oxytocin usage [ Time Frame: At the time of the end of the labor ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Instrumental delivery [ Time Frame: At the time of the end of the labor ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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
Genders 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
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

No publications provided

Responsible Party: Fu Zhou Wang, Dr, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02036242     History of Changes
Other Study ID Numbers: NJFY13007, JQX12009
Study First Received: January 11, 2014
Last Updated: February 1, 2014
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Opioid
Local anesthetic
Labor delivery
Safety

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

ClinicalTrials.gov processed this record on April 16, 2014