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Completed

NCT Number: NCT02036242

Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sole local anesthetic

Drug

0.125% ropivacaine 10-15 ml every 1h during labor delivery

Other names: Ropivacaine, Naropin

Sufentanil (Opioid plus local anesthetic)

Drug

Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery

Other names: Naropin

Ropivacaine

Drug

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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 outcomes

  1. Time to latent phase

    Time frame: From the beginning of regular contraction of uterus to the dilation of cervical 4cm

    Record the time duration

  2. Time of active phase

    Time frame: From the cervix 4cm to the dilation of cervical 10cm

    Record the time duration

  3. 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

  4. 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

  5. Neonatal Apgar score

    Time frame: At the time of the baby was born, 1min, 5min, 10min and 20min

  6. 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.

  7. Umbilical gas analysis

    Time frame: At the time of the fetus was delivery

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: OLAA

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2014
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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